Careers

Kardium has built an exceptional team with expertise in medicine, business, engineering, quality and manufacturing. We hire only the best individuals whom are highly motivated and strong team players and we trust them to make the right decisions to achieve our goals. We also believe in having fun while working hard.

Kardium is located in greater Vancouver, Canada, a vibrant and diverse urban centre surrounded by abundant natural attractions and ranked globally as one of the best cities to live in.

We are consistently named one of the top companies in British Columbia to work for and were awarded “Medical Technology Company of the Year” by LifeSciences BC in 2015.

We offer a flexible work environment, a comprehensive salary and benefits program, and the ability to participate in equity through a stock option plan.


Working at Kardium

Working at Kardium provides:

  • A positive impact every day helping treat a condition that debilitates millions worldwide
  • The ability to be involved in the development of a sophisticated medical device
  • A great working environment with opportunities to develop your skills and knowledge
  • An engaged leadership team who believes in mentoring and career growth
  • Supportive colleagues and fun social events to foster teamwork

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Current openings

If you would like to receive an email when new job opportunities are posted, send an email to jobs@kardium.com with “Subscribe to new job postings” in the subject line.

Production Technician
Clinical Affairs Manager
Electrical Verification and Validation Engineer
Regulatory Affairs Manager
Clinical Project Manager
Manufacturing Automation Engineer
Purchasing Agent
Supplier Quality Engineer
Quality Control Technician
Electronics Engineer
Quality Control Team Lead
Mechanical Verification Engineer
Mechanical Verification Technician
Electrical-System Risk Management Engineer
Quality Engineer (12-month Contract)
Mechanical Risk Management Engineer
Software and Systems Test Engineer


Production Technician

Kardium is looking for talented and driven Production Technicians to join our manufacturing team in a permanent capacity. Our Production Technicians work in a multi-disciplinary environment with other members of the manufacturing team in the preparation, assembly, and testing of medical devices. Kardium offers a comprehensive compensation and benefits program, and the ability to participate in equity through a stock option plan. Essential abilities of the successful candidate include strong technical aptitude and hands-on skills, as well as the ability to work with minimal supervision.

Responsibilities

  • Preparation of electrical and mechanical parts required for assembly of medical devices using an array of hand and power tools as well as custom jigs and fixtures
  • Assembly of miniature precision components using a variety of methods including adhesives, fasteners, and laser-welding
  • Conducting tests to assess quality and reliability of device components and documenting the results
  • Detailed adherence to standard operating procedures for assembly and testing of device components
  • Working with engineering team to pilot novel manufacturing process technologies
  • Occasional operation of manual machine shop tools
  • The ability to work both morning and afternoon shifts

Experience

  • Excellent hand-eye coordination especially when working with a microscope
  • Experience with assembly of miniature mechanical components
  • Experience with basic electro-mechanical parts assembly, such as soldering and crimping
  • Experience with machine-tool operation

Personal Attributes

  • Highly dedicated, self-motivated and self-managed
  • Able to work with minimal supervision in a multi-disciplinary team environment
  • Excellent problem solving abilities and attention to detail
  • Excellent written and verbal communication and technical documentation skills
  • Good interpersonal skills, including maturity, teamwork, respect, courtesy, tact, and discretion
  • A strong drive to succeed with a track record of being highly productive
  • Ability to deal with changing priorities and requirements
  • Strong leadership skills with experience in delivering training

Desired Assets

  • Familiarity with assembly and testing requirements of medical devices and associated documentation
  • Prior exposure to Good Manufacturing Practices and working in a clean room

How to Apply

Recruitment is ongoing as there are multiple positions. You are encouraged to apply by sending a cover letter and résumé to jobs@kardium.com. Please use “071 Production Technician” as the subject line of your email.


Clinical Affairs Manager

The Clinical Affairs Manager is responsible for devising and executing clinical trial strategies for cardiovascular therapeutic products. The Manager will define the clinical requirements for a wide range of medical device projects and drive the clinical development and validation strategies, and he/she will collaborate with the Regulatory Affairs team, as well as other teams to successfully support multiple PMA and 510(k) submissions in the United States and CE marking under the MDD and MDR in the EU. These trials are complex, consisting of several sub-studies and multiple clinical sites. The position provides senior clinical leadership internationally and across functions, reports to the Head of Quality and Regulatory, located in Vancouver, BC, Canada. The position may be located in Canada or the United States.

Responsibilities

  • Represent Clinical Affairs in the strategic planning of medical device projects, and collaborate with the Regulatory Affairs, Research, and Business Development teams to develop the medical strategies for new products and define their potential medical value.
  • Establish general clinical affairs policies and procedures in accordance with applicable regulatory requirements, GCP, international standards and industry practice, as well as monitor proposed regulations and guidance documents related to clinical trials and personal data privacy to ensure that all clinical activities, policies, and procedures remain compliant with these requirements.
  • In close collaboration with key opinion leaders and internal Subject Matter Experts, drive the design of clinical studies and ensure their adequacy to successfully support premarket regulatory submissions and post-market surveillance of the company’s product in the US, Canada, and Europe.
  • Ensure, either by direct execution or by providing oversight, the timely completion and compliance of clinical trial activities, including:
    • Design, implementation, and validation as required of electronic CRFs, clinical database and data transmission, and management infrastructure
    • Budgeting and negotiation of contracts with investigational sites, investigators, and their clinical research staff
    • Recruitment and initiation of investigational centres
    • Collaboration with Clinical Training Coordinator to plan, deliver, and document training to investigators, study nurses, and research assistants
    • Authoring and maintenance of required study documentation (trial master file, site study binders, study protocol, CRFs, informed consent forms, etc.)
    • Coordination of monitoring, auditing, and GCP compliance of investigational sites
    • Adverse event triaging and collaboration with the Regulatory Affairs team for the timely submission of mandatory and periodic safety reports to regulatory bodies, IRBs, and ECs
    • Coordination with external monitors and CROs as required
    • Site closure
    • Study report authoring and approval
  • Provide support to the Regulatory Affairs team for the timely completion of regulatory submissions.
  • Build, develop, and provide leadership to the Clinical Affairs team of the organization.
  • Serve as the scientific and clinical liaison between internal teams and external groups such as key opinion leaders, professional, and public health organizations, advisory boards, regulatory authorities, and CROs.

Education and Experience

  • M.Sc. or Ph.D. preferably in biomedical engineering or biotechnology
  • 10+ years of experience in medical device clinical trial research and regulatory submissions for clinical studies (IDE, IRB, Health Canada ITA, European CA and EC) ranging from early feasibility to pivotal and post-market stages
  • 5+ years of management experience, with proven track record of delivering projects on time and promoting high performance behaviors within a team
  • Prior experience working with cross-functional project teams, IRBs, and business partners
  • Experience in interfacing with key opinion leaders including physicians, specialty clinical, and research teams

Required Knowledge/Skills

  • Thorough, working knowledge of clinical trial design and biostatistics, with a clear understanding of the intersection between study design, statistical design, regulatory strategy, and intended use.
  • Understanding of regulations and guidelines governing medical devices, with a broad knowledge of requirements and best practices in Clinical Affairs, Regulatory Affairs, and Product Development.
  • Ability to provide medical expertise and leadership to the Clinical, Regulatory Affairs, Quality Assurance, Research, Engineering, and Business Development teams.
  • Proven ability to multitask, collaborate in cross-functional teams, work independently, and manage multiple time-sensitive high priority projects.
  • Excellent communication skills and working knowledge of English grammar, punctuation, and overall writing skills, with the ability to write clinical trial reports and documentation independently.
  • Critical-thinker with excellent negotiation skills and the ability to address complex situations independently.
  • Ability to develop or revise clinical trial procedures and processes, and working knowledge of clinical trial auditing.
  • Willingness to travel up to 40%.

Preferred Knowledge/Skills, Education, and Experience

Professional designations are not required, but training and certificates in clinical research, quality, or regulatory affairs are a plus (e.g., ACRP, SOCRA, GCP, RAC, etc.).

How to Apply

To apply for this position, please send a résumé and cover letter to jobs@kardium.com. Please use “127 Clinical Affairs Manager” as the subject line of your email.


Electrical Verification and Validation Engineer

Your opportunity…

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. In this role, you will gain hands-on experience in the development and commercialization of complex and leading-edge medical devices.

What you’ll be doing…

You will engage in activities such as:

  • Designing and executing full-system and board-level testing of the company’s medical devices, on circuitry such as high frequency power amplifiers, precision measurement systems, and cabling
  • Performing and assisting with electrical compliance testing
  • Developing automated data analysis tools for measuring system accuracy and performance
  • Participating in design input and design output reviews of new designs
  • Performing root cause analyses and risk analyses related to performance of the devices’ electronics and software systems
  • Drafting regulatory-facing test protocols and test reports

What you bring to the team…

Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable. You are suited to our approach and possess these attributes:

  • A bachelor’s degree in electrical engineering or engineering physics
  • Experience with electrical circuit analysis, signal processing, and hands-on electrical experience
  • A strong grasp of mathematics, statistics, and software analysis tools including Matlab and C#
  • Familiarity with medical electrical safety standards such as EN 60601 and ISO 14971
  • Excellent communication and documentation skills
  • Positive, proactive attitude and be able to execute tasks with an appropriate level of independence
  • Enthusiastic about seeking innovative solutions to unforeseen challenges
  • Demonstrated success working in a team setting

Why work at Kardium?

Working at Kardium provides:

  • A positive impact every day helping treat a condition that debilitates millions worldwide
  • The ability to be involved in the development of a high-complexity medical device
  • A great working environment with opportunities to develop your skills and knowledge
  • An engaged leadership team who believes in mentoring and career growth
  • Supportive colleagues and fun social events to foster teamwork

How to apply…

If this position appeals to you, apply today by sending your résumé and cover letter to jobs@kardium.com. Please use “128 Verification and Validation Engineer” as the subject line of your email. And if you are a recent grad, please attach your most recent transcripts.


Regulatory Affairs Manager

Kardium is looking for a talented individual to lead our Regulatory Affairs (RA) department. As the RA Manager, you will be responsible for planning and coordinating our worldwide regulatory submissions to obtain and maintain investigational and marketing approvals, clearances, and registrations for our products. You will also be responsible for assessing changes for impact on regulatory filings worldwide, ensuring labelling compliance, and researching and providing guidance and advice to colleagues on regulatory issues. This position will fulfill, by direct execution or through oversight, the following main responsibilities:

  • Providing input into Kardium’s regulatory strategy for medical device projects
  • Representing RA on product development project teams to ensure all regulatory requirements are met throughout the product’s life-cycle
  • Creating and maintaining product EU technical files and design dossiers
  • Planning and preparing worldwide regulatory submissions, including, but not limited to, Investigational Device Exemptions (IDE), 510(k)s, Pre-Market Approval (PMA) applications, PMA supplements, CE marking applications, and Health Canada licensing applications for all medical device classes
  • Interacting with regulatory agencies as required for the processing of submissions, regulatory reports, and any other regulatory actions
  • Maintaining the regulatory status of Kardium products
  • Maintaining regulatory files/database and chronologies in adequate order; establishing and maintaining systems for tracking submissions, and changes thereof, sent to agencies and partners
  • Reviewing marketing material, labeling specifications, and label content for compliance with regulatory requirements
  • Evaluating changes to documents, products, processes, and test methods for report-ability
  • Determining the report-ability of field events and filing event reports with regulatory agencies as required
  • Maintaining current knowledge of EU, FDA, and international regulation, guidance, and standards applicable to the company’s products; researching regulatory issues, disseminating regulatory information, and applying appropriate implementation strategies in response to shifting requirements
  • Coordinating the outsourcing of projects to, and collaborating with, RA consultants as required
  • Developing and providing leadership to the RA team

Experience & Qualifications

  • Bachelor of science or engineering degree (M.Sc. an asset)
  • A minimum of 7 years of relevant regulatory affairs experience, including 3 or more years in a managerial role
  • Experience with Class II devices is mandatory (Class III preferred)
  • In-depth working knowledge of European, US, and international medical device regulatory requirements

Personal Attributes

  • Excellent written and verbal communication and technical documentation skills
  • Strong interpersonal and negotiating skills
  • Strong organizational, project management, and leadership skills
  • Extreme attention to detail
  • Ability to plan and manage complex, multiple projects with minimal instruction and guidance
  • A sense of urgency, agility, transparency, respect, and collaboration in a team setting
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat
  • Flexible and adaptable to take on additional responsibilities as appropriate

How to Apply

If you are interested in this position, please send an email with your resume and cover letter to jobs@kardium.com with a subject line of “136 Regulatory Affairs Manager”.


Clinical Project Manager

Kardium has an exciting opportunity for a Clinical Project Manager. The Clinical Project Manager will be responsible for the planning, management, and execution of all clinical study activities at Kardium. This position will report to the Head of Quality and Regulatory, located in Vancouver, BC, Canada. This position may be located in Canada or the United States.

Responsibilities

  • Coordinate Kardium’s clinical study activities in the US, Canada, and Europe
  • Recruitment and management of clinical internal and external support staff
  • Ensure clinical study documentation is complete per GCP
  • Handle clinical enquiries and reports from clinical sites, including adverse event reporting
  • Liaise with Regulatory team and clinical sites
  • Collaborate with Quality team to co-ordinate site initiation, monitoring, auditing, and GCP compliance of sites

Education and Experience

  • Bachelor’s degree in science, engineering, or equivalent
  • Experience in planning and running a clinical study
  • Strong working knowledge of quality systems for medical devices
  • Experience working directly with doctors and hospital staff

Required Skills

  • Excellent leadership and interpersonal skills
  • Strong analytical skills and critical thinking
  • Ability to communicate effectively with physicians
  • Effective written and verbal communication and technical documentation skills
  • Able to operate independently with minimal direction
  • Flexible and adaptable to take on additional responsibilities as appropriate
  • Willingness to travel up to 40%

How to Apply

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “137 Clinical Project Manager” in the subject line.


Manufacturing Automation Engineer

Your opportunity…

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. In this role, you will gain hands-on experience in the development and commercialization of complex and leading-edge medical devices.

What you’ll be doing…

You will engage in a diverse set of activities such as:

  • Capture and documentation of requirements for automated manufacturing equipment
  • Design and implementation of software (C#), firmware, and electronics for automated manufacturing equipment
  • Organization of and participation in multi-disciplinary design reviews related to automated manufacturing equipment
  • Transfer of the automated equipment to manufacturing and provision of ongoing support

What you bring to the team…

Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable. You are suited to our approach and possess these attributes:

  • Bachelor’s degree or higher in an engineering discipline
  • Software and hardware development skills and knowledge normally acquired through at least three years of experience
  • Object-oriented programming experience
  • Experience developing firmware for embedded systems
  • Experience with data acquisition, motion control, machine vision, and database development
  • Experience with high volume, high precision manufacturing
  • A strong drive to succeed with a track record of being highly productive
  • Excellent problem-solving skills and attention to detail
  • Excellent written and verbal communication and technical documentation skills
  • Able to deal with changing priorities and requirements
  • Able to execute tasks with minimal instruction and guidance
  • Able to rapidly understand new concepts and acquire new skills

Why work at Kardium?

Working at Kardium provides:

  • Work on medical devices that will improve people’s lives
  • Involvement in the development of a high-complexity medical device
  • A great working environment with opportunities to develop your skills and knowledge
  • An engaged leadership team who believes in mentoring and career growth
  • Supportive colleagues and fun social events to foster teamwork
  • Competitive compensation, including equity participation

How to apply…

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “138 Manufacturing Automation Engineer” in the subject line. Indicate in your cover letter why you are interested in Kardium and why you are interested in this specific position.


Purchasing Agent

About the Job

The Purchasing Agent is accountable for all day-to-day activities of managing procurement of goods and services and ensuring delivery commitments, as well as all contractual and regulatory requirements are met. The successful candidate is responsible for developing and maintaining supplier relationships and managing communication between suppliers and multiple internal stakeholders. The Purchasing Agent actively manages supply capacity and identifies opportunities to improve all supply chain metrics. The role will involve significant material planning, purchasing and cost control through all product life cycle stages, and offers the opportunity to become involved in the commercialization of cutting-edge medical devices.

Responsibilities

  • Obtain price quotations from suppliers and ensure current pricing remains validated
  • Create and release purchase orders for production goods and services
  • Proactively review upcoming deliveries and ensure identified delivery risks are mitigated
  • Expedite or de-expedite material purchases as necessary
  • Continuously engage with suppliers to understand capacity and other supply constraints and ensure internal stakeholders are updated in a timely manner
  • Establish and maintain effective working relationships and ensure an escalation strategy is in place for all suppliers
  • Ensure Kardium’s requirements are communicated to suppliers
  • Assist with the supplier qualification and part approval (PPAP) processes
  • Identify opportunities to improve quality, cost, and on-time delivery, and to reduce supply risk
  • Facilitate disposition and/or return of non-conforming parts and ensure corresponding credits are received from the supplier
  • Ensure approved deviation permits are communicated to suppliers and that all required documentation is in place prior to supplier shipment
  • Provide purchasing support for engineering and other non-production activities and cross-functional projects

Experience & Qualifications

  • Bachelor’s degree or diploma in business, engineering, or the sciences
  • Minimum 3 years of purchasing or other supply chain experience
  • Possession of SCMA/APICS or other purchasing accreditation is beneficial
  • Experience working in an ISO13485 or AS9100 regulated environment desirable
  • Knowledge of and ability to practically apply concepts of supplier relationship management
  • Understanding of materials management and control
  • Experience working with ERP/MRP systems
  • Proven ability to identify and implement opportunities for improvement

Personal Attributes

  • Can communicate effectively at all levels with both internal and external stakeholders
  • Proven ability to meet deadlines and deliver results in a fast-paced, schedule-driven environment
  • Strong organizational skills with ability to prioritize and manage multiple competing deliverables
  • Proactive outlook with the ability to anticipate potential risks and drive appropriate actions
  • Focus on customer service with the desire to exceed internal customer expectations
  • Flexible and willing to take on additional responsibilities as required

How to Apply

To apply for this position, please send a résumé and cover letter to jobs@kardium.com with the job title “148 Purchasing Agent” in the subject line.


Supplier Quality Engineer

Candidate Profile

The Supplier Quality Engineer (SQE) is a key member of the Supply Chain Team and comes with demonstrated leadership skills and ability to improve supplier quality. The SQE participates in supplier selection, approval and review processes, and develops and implements plans to address supplier quality system or process concerns. The role manages all containment of supplier non-conforming goods and ensures investigations are completed in a timely fashion and that supplier corrective actions are fully implemented and effectiveness validated. The SQE works in close cooperation with the risk management, engineering, and testing teams to achieve a high level of supplier quality performance and ensure supplier-related quality risks are identified and mitigated early on. The position offers an opportunity to take the lead in driving significant improvement to supplier quality and supply chain metrics and to help create and execute on Kardium’s overall supply chain strategy.

Responsibilities

  • Ensure initial investigation and root cause analysis for all supplier non-conformances are documented and acceptable
  • Participate in MRB assessment and disposition of supplier non-conformances and drive containment of all affected Kardium inventory
  • Initiate supplier containment and corrective and preventative actions, and ensure quality issues are resolved
  • Drive development and implementation of supplier control plans in conjunction with risk management input
  • Lead development of a “Certified Supplier” program enabling dock-to-stock receipt or reduced incoming inspection requirements of raw materials
  • Assist procurement in identifying suppliers with capabilities that will meet Kardium requirements
  • Participate in or lead supplier quality management system and manufacturing process audits and drive follow-up actions to completion
  • Lead evaluation and implementation of PPAP requirements for new part introductions and ensure all part qualifications are completed on time
  • Lead periodic reviews of supplier performance metrics and ensure corrective actions are communicated, implemented, and effectiveness verified
  • Process acceptable raw material deviations through to completion ensuring approval by all key stakeholders is documented
  • Actively engage suppliers in identification of design-for-manufacture (DFM) opportunities and ensure

Experience and Qualifications

  • Bachelor degree in mechanical, electrical, or industrial engineering
  • Minimum 4-5 years in a supplier quality engineering role
  • Experience in a high volume, technically-complex manufacturing environment preferred
  • Diverse knowledge of mechanical manufacturing processes is an asset
  • Must demonstrate an understanding of the practical application of risk assessment and management
  • Excellent root cause analysis and problem solving skills
  • Understanding of quality management tools (8D problem solving, 5W2H, Ishikawa diagram)
  • Understanding of statistical analysis as applied to quality
  • Experience in auditing to ISO13485 or AS9100 standards
  • ASQ quality engineer certification is an asset
  • Well-developed understanding of supplier relationship management
  • ERP/MRP experience preferred
  • Ability to travel worldwide as required

Personal Attributes

  • Ability to deliver results in a fast-paced, schedule-driven environment while managing multiple, competing deliverables
  • Strong leadership and interpersonal skills with the ability to drive actions and initiatives to conclusion externally and internally across multiple departments.
  • Highly effective oral and written communication skills with the ability to clearly explain complex topics to multiple functions at all levels of the organization
  • Superior ability to understand and communicate highly technical specifications and requirements
  • Flexible and willing to take on additional responsibilities as assigned

How to Apply

To apply for this position, please send a résumé and cover letter to jobs@kardium.com with the job title “149 Supplier Quality Engineer” in the subject line.


Quality Control Technician

Your opportunity…

By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a ground breaking medical device for the non-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. As a member of the quality assurance function, you will have direct responsibility for Kardium’s daily quality control activities to support the product release of the Globe. As a valued member of the QA team you will collaborate with the Engineering and Manufacturing teams in planning and executing our quality assurance. Critical to the success of this function is your high attention to detail and rigor to follow established protocols to ensure all regulatory standards are met.

What you’ll be doing…

As the Quality Control Technician, your responsibilities include:

  • Sampling, inspection, and measurement of incoming raw materials, in-process, and finished devices according to established material and component specifications, and quality control specifications and procedures.
  • Producing formal reports of the inspection and measurement results and initiating non-conformity reports (NCR) when required.
  • Conducting the cleaning, maintenance, and calibration of measuring equipment.

What you bring to the team…

Our Kardium team is smart, creative, and passionate about creating a cutting edge medical device to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable. You bring to the team these characteristics, plus:

  • At least five years of hands-on quality control experience where you developed a working knowledge of medical device standards and regulatory requirements pertaining to quality control and demonstrated your proficiency with advanced measurement tools/systems, such as vision‐based systems and CMMs.
  • An associate degree or diploma in a technical field, or equivalent combination of education, technical training, and/or related experience.
  • Demonstrated excellent knowledge of geometric dimensioning and tolerancing (GD&T) principles and terminology.
  • Proven competence in appropriately interpreting and following detailed inspection and test procedures, as well as documenting results accurately.
  • An ability to interpret mechanical drawings to understand specified dimensional and functional characteristics to be measured, tested, or inspected.
  • A sound understanding of ISO 13485, cGMPs, and regulatory requirements pertaining to quality control.
  • A high level of proficiency with standard measurement tools/systems (calipers, micrometers, height gauges, dial indicators, force gauges, etc.).
  • Well-developed written and verbal communication and technical documentation skills.
  • The willingness and ability to take on additional responsibilities as appropriate.

Why work at Kardium?

We know you are looking for a meaningful career. We can offer you that, and more:

  • Every day you know you are making a difference by helping treat a condition that debilitates millions of people worldwide.
  • A great working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology.
  • An engaged leadership team who believes in mentoring and growing employees’ careers.
  • Supportive colleagues and plenty of fun social events to encourage employee interactions.
  • And our employees think we are great too – check out Glassdoor to learn more.

How to apply…

If this position appeals to you, apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “150 Quality Control Technician” in the subject line. And if you are a recent grad, please include your GPA in your resume.


Electronics Engineer

Your opportunity…

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. In this role, you will gain hands-on experience in the development and commercialization of complex and leading-edge medical devices.

What you’ll be doing…

You will engage in a diverse set of activities such as:

  • Analog and digital circuit design, including: documentation, schematic capture, and PCB layout.
  • VHDL coding of synthesizable control electronics and test benches.
  • Testing prototypes of custom electronics.
  • Supporting design transfer to manufacturing and service.
  • Investigating and determining the root cause of technical failures.

What you bring to the team…

Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable. You are suited to our approach and possess these attributes:

  • Bachelor’s degree or higher in electrical or electronics engineering.
  • Electronics engineering skills and knowledge normally acquired through at least three years of experience.
  • Experience with electronics CAD tools.
  • Proficiency with test and measurement equipment.
  • Board level analog and digital circuit design experience.
  • A strong drive to succeed with a track record of being highly productive.
  • Excellent problem-solving skills and attention to detail.
  • Excellent written and verbal communication and technical documentation skills.
  • Able to deal with changing priorities and requirements.
  • Able to execute tasks with minimal instruction and guidance.
  • Able to rapidly understand new concepts and acquire new skills.
  • Experience developing electronics for a medical device.
  • Experience with safety and EMC standards, particularly IEC 60601.
  • Experience with Altium Designer.
  • Experience with VHDL and Xilinx FPGA workflows and tools.
  • Experience with MATLAB.

Why Work at Kardium?

Working at Kardium provides:

  • Work on medical devices that will improve people’s lives.
  • Involvement in the development of a high-complexity medical device.
  • A great working environment with opportunities to develop your skills and knowledge.
  • An engaged leadership team who believes in mentoring and career growth.
  • Supportive colleagues and fun social events to foster teamwork.
  • Competitive compensation, including equity participation.

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, using “151 Electronics Engineer” as the subject line. Indicate in your cover letter why you are interested in Kardium and why you are interested in this specific position.


Quality Control Team Lead

Your opportunity…

By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a groundbreaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. As a member of the Quality Assurance (QA) function, you will have direct responsibility for Kardium’s quality control activities to support product release. You will collaborate with the engineering and manufacturing teams in planning and executing our QA program. Critical to the success of this function is your high attention to detail and rigor to follow established protocols to ensure all regulatory standards are met.

What you’ll be doing…

As the Quality Control Team Lead, your responsibilities include:

  • Leading the development of quality control procedures within the manufacturing process, with focus on mechanical subsystems
  • Ensuring that adequate IM&TE is specified for the metrology needs of the company’s medical device projects, and that the company’s metrology laboratory and IM&TE continues to be suitable
  • Ensuring that IM&TE is adequately maintained, calibrated, and documented at all times
  • In collaboration with the Quality Control Planner, coordinating quality control activities, mainly incoming and in-process inspections
  • Coordinating quality control support for various research and development activities
  • Reviewing and approving quality control inspection specifications
  • Supporting root cause investigations and resolution of quality problems
  • Undertaking hands-on quality control tasks to add bandwidth to the Quality Control Team as needed
  • Identifying quality control human resource needs and maintaining adequate staffing of the Quality Control Team
  • Planning and imparting training to quality control staff and maintaining training records

What you bring to the team…

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable. You bring to the team these characteristics, plus:

  • Bachelor’s degree in engineering or other applied science, or equivalent
  • Minimum of 5 years of quality control experience in a regulated manufacturing environment, preferably including management of quality control staff and operations
  • Extensive experience with standard measurement tools/systems (calipers, micrometers, height gauges, dial indicators, force gauges, etc.), and with advanced, high-precision CMMs and optical measurement equipment for micro-scale metrology applications, such as complex-featured mechanical parts and subsystems
  • Demonstrated excellent knowledge of Geometric Dimensioning & Tolerancing (GD&T) principles and terminology
  • An in-depth knowledge of ISO 13485, medical device cGMPs, and regulatory requirements pertaining to quality control
  • Excellent leadership and interpersonal skills
  • Strong analytical skills and critical thinking
  • Well-developed written and verbal communication and technical documentation skills
  • The willingness and ability to take on additional responsibilities as appropriate

Why work at Kardium?

We know you are looking for a meaningful career. We can offer you that, and more:

  • Every day you know you are making a difference by helping treat a condition that debilitates millions of people worldwide
  • A great working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology
  • An engaged leadership team who believes in mentoring and growing employees’ careers
  • Supportive colleagues and plenty of fun social events to encourage employee interactions
  • And our employees think we are great too – check out Glassdoor to learn more

How to apply…

If this position appeals to you, apply today by sending your résumé and cover letter to jobs@kardium.com, using “152 Quality Control Team Lead” as the subject line.


Mechanical Verification Engineer

Your opportunity…

By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. In this role, you will gain hands-on experience in the development and commercialization of complex and innovative medical devices.

What you’ll be doing…

You will engage in activities such as:

  • Developing test methods to characterize product performance and inform design and manufacturing decisions
  • Designing and fabricating test fixtures and jigs using CAD and CAM software
  • Working with third party test labs and developing expertise in relevant medical device standards and industry accepted test methods
  • Driving continuous improvement of company practices as they pertain to verification and validation.
  • Collaborating with stakeholders across the company to initiate and resolve investigations.

What you bring to the team…

Our Kardium team is smart, creative, and passionate about developing innovative medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable. You are suited to our approach and possess these attributes:

  • Bachelor’s degree or higher in engineering (mechanical, mechatronics, or engineering physics is preferred)
  • At least 3 years of experience with design verification and validation of mechanical components and systems in the biotechnology, pharmaceutical, diagnostics, of medical device industry, or 5 years of hands on experience with mechanical or electro-mechanical testing in industry
  • Practical knowledge of mechanical systems, experimental design, and statistics as applied to verification and validation testing
  • Experience in a laboratory environment, including proper experimental data collection and good documentation practice
  • Detail oriented with a sound ability to manage multiple tasks accurately and in a timely manner
  • Positive, proactive attitude and be able to execute tasks with an appropriate level of independence

Why work at Kardium?

Working at Kardium provides:

  • A positive impact every day helping treat a condition that debilitates millions worldwide
  • The ability to be involved in the development of a high-complexity medical device
  • A great working environment with opportunities to develop your skills and knowledge
  • An engaged leadership team who believes in mentoring and career growth
  • Supportive colleagues and fun social events to foster teamwork

How to apply…

To apply for this position, please send a cover letter and résumé to jobs@kardium.com using “153 Mechanical Verification Engineer” as the subject line. And if you are a recent grad, please attach your most recent transcripts.


Mechanical Verification Technician

Your opportunity…

By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. In this role, you will gain hands-on experience in the development and commercialization of complex and innovative medical devices.

What you’ll be doing…

You will engage in activities such as:

  • Executing test protocols and authoring detailed reports to validate Kardium’s manufacturing processes
  • Working with third-party test labs and developing expertise in relevant medical device standards and industry accepted test methods
  • Maintaining test equipment and facilities, including inventory management of test samples

What you bring to the team…

Our Kardium team is smart, creative, and passionate about developing innovative medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable. You are suited to our approach and possess these attributes:

  • Associates degree or higher in engineering (mechanical, electrical, or physics)
  • Excellent communication skills and good documentation practices
  • Practical knowledge of mechanical systems, experimental design, and measurement systems analysis
  • Positive, proactive attitude with ability to execute tasks with an appropriate level of independence
  • Enthusiastic about seeking innovative solutions to unforeseen challenges
  • Demonstrated success working in a team setting

Why work at Kardium?

Working at Kardium provides:

  • A positive impact every day helping treat a condition that debilitates millions worldwide
  • The ability to be involved in the development of a high-complexity medical device
  • A great working environment with opportunities to develop your skills and knowledge
  • An engaged leadership team who believes in mentoring and career growth
  • Supportive colleagues and fun social events to foster teamwork

How to apply…

To apply for this position, please send a cover letter and résumé to jobs@kardium.com using “154 Mechanical Verification Technician” as the subject line. And if you are a recent grad, please attach your most recent transcripts.


Electrical-System Risk Management Engineer

Your opportunity…

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a groundbreaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure and other heart-related complications. As part of the Quality Engineering team, you will coordinate risk management activities related to electrical and software subsystems of the company’s products in close cooperation with the Engineering and Manufacturing teams, and assure the timely and accurate evaluation of risk in engineering projects. Critical to the success of this function is strong analytical skills, high attention to detail, rigor in analyzing risks, and ensuring all regulatory standards are met.

What you’ll be doing…

As the Electrical-System Risk Management Engineer, your responsibilities include:

  • Authoring and maintaining design and process Failure Mode and Effects Analyses (dFMEAs and pFMEAs) and associated documentation including process requirements related to electrical subsystems
  • Authoring and maintaining system-level software hazard analyses
  • Authoring the risk assessment of change control documentation and of deviation permits
  • Participating in electrical subsystem and software system-level design reviews to ensure that risk management is an integral part of the reviews; assisting in establishing and reviewing traces between risk items and process and product specifications in order to maintain consistent forward and backward traceability
  • Providing assistance and guidance to the Engineering and Testing teams in the design of test plans and protocols based on the associated risks analyses
  • As a member of the Material Review Board, participating in the review and disposition of non-conforming products and material
  • Conducting the risk review of work instructions and material reworks
  • Assisting the Electrical team with root cause investigations and corrective and preventive actions (CPAs)

What you bring to the team…

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable. You bring to the team these characteristics, plus:

  • Bachelor of science or engineering degree (electrical or electronics engineering is preferred)
  • A minimum of 3 years’ experience in a regulated industry, preferably in biotechnology
  • Working knowledge of risk management process (e.g., ISO 14971) and hands-on experience with risk management tools (Failure Mode and Effect Analysis, Fault Tree Analysis, etc.)
  • Knowledge of probability and statistics related to risk management
  • Excellent written and verbal communication and technical documentation skills
  • Strong analytical and interpersonal skills
  • Ability to come up to speed quickly on complex subject matter
  • Flexible and adaptable to meet the needs of varying production schedules, and to take on additional responsibilities as appropriate

Why work at Kardium?

We know you are looking for a meaningful career. We can offer you that, and more:

  • Every day you know you are making a difference by helping treat a condition that debilitates millions of people worldwide
  • A great working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology
  • An engaged leadership team who believes in mentoring and growing employees’ careers
  • Supportive colleagues and plenty of fun social events to encourage employee interactions
  • And our employees think we are great too – check out Glassdoor to learn more

How to apply…

If this position appeals to you, apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “155 Electrical-System Risk Management Engineer” in the subject line.


Quality Engineer (12-month Contract)

Your opportunity…

By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a ground breaking medical device for non-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

In this role, you will help define our quality planning standards and establish our team structure to support the successful launch of the Globe and its ongoing production. As the subject matter expert, you will work closely with the Engineering and Manufacturing teams to plan the key aspects of quality assurance and would be heavily involved in the quality engineering of cutting-edge medical devices.

The position is a 12-month contract with a strong possibility of becoming permanent.

What you’ll be doing…

Your role will evolve over the product life cycle. Initially you will focus on the planning for, and ensuring, consistent quality is produced for pre-clinical and early clinical testing and then your focus will shift to manufacturing and operations support in the later stages of the commercialization process. You will apply your ISO 13485 and US FDA QSR expertise and quality engineering knowledge to assist the Quality Assurance, Engineering, and Manufacturing teams in the identification and resolution of quality issues.

In the design transfer phase, you will collaborate with Engineering and Manufacturing to ensure products are effectively and appropriately transferred to production. Specifically:

  • Supporting the development and implementation of Control Plans
  • Collaborating with the Risk Management Team in the conduct and documentation of process risk analyses
  • Maintaining the planning and implementation of process capability and stability assessment and monitoring systems
  • Assisting the Quality Control and Engineering teams in the development and optimization of incoming and in-process quality control procedures

In the production and post-production phases:

  • Supporting production change control activities, including maintenance of Control Plans
  • Participating in the review of nonconforming product and materials as required
  • Monitoring and evaluating product quality, and process stability and capability
  • Identifying trends, and provide solutions for corrections or improvements
  • Working collaboratively with Manufacturing to solve in-house quality issues by participating in the conduct of nonconformity investigations and root-cause analysis, and recommending corrective action to prevent recurrence
  • Contributing to the assessment of post-market surveillance feedback and implement any resulting corrective and preventive actions, and necessary improvements to process controls

What you bring to the team…

Our Kardium team is smart, creative, and passionate about creating a cutting edge medical device to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable. You bring to the team these characteristics, plus:

  • A bachelor of science degree (mechanical, applied physics, etc.) or equivalent engineering degree
  • At least 3 years of quality engineering experience in a multi-disciplinary environment in a regulated industry, preferably in the area of high-risk medical devices
  • In-depth knowledge of metrology, as well as quality planning, execution, coordination, and documentation
  • A sound knowledge of statistics, SPC, FMEA, and process capability
  • Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation
  • Proven written and verbal communication and technical documentation skills
  • Well-developed interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization
  • The willingness and ability to take on additional responsibilities as appropriate

Why work at Kardium?

We know you are looking for a meaningful career. We can offer you that and more:

  • Every day you know you are making a difference in the people’s lives by helping treat a condition that debilitates millions worldwide
  • A great working environment with opportunities to develop your skills and knowledge
  • An engaged leadership team who believes in mentoring and growing employees’ careers
  • Supportive colleagues and plenty of fun social events to encourage employee interactions
  • And our employees think we are great too – check out Glassdoor to learn more!

How to apply…

If this position appeals to you, apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “156 Quality Engineer” in the subject line. And if you are a recent grad please include your GPA in your resume.


Mechanical Risk Management Engineer

Your opportunity…

By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a groundbreaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

As part of the Quality Engineering team, you will coordinate risk management activities related to the mechanical subsystems of the company’s products in close cooperation with the Engineering and Manufacturing teams, and assure the timely and accurate evaluation of risk in engineering projects. Critical to the success of this function is strong analytical skills and your high attention to detail and rigor in analyzing risks and ensuring all regulatory standards are met.

What you’ll be doing…

As the Mechanical Risk Management Engineer, your responsibilities include:

  • Authoring and maintaining design and process Failure Mode and Effects Analyses (dFMEA and pFMEAs) and associated documentation including process requirements.
  • Authoring the risk assessment of Change Control documentation and of Deviation Permits.
  • Participating in (mechanical system) design reviews to ensure that risk management is an integral part of the reviews. Assisting in establishing and reviewed traces between risk items and process and product specification items in order to maintain consistent forward and backward traceability.
  • Providing assistance and guidance to the Engineering and Testing teams in the design of test plans and protocols based on the associated risk analyses.
  • As a member of the Material Review Board, participating in the review and disposition of non-conforming products and material.
  • Conducting the risk review of Work Instructions and material reworks.
  • Assisting the Mechanical and Manufacturing teams with root cause investigations and corrective and preventive actions (CAPAs).

What you bring to the team…

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable. You bring to the team these characteristics, plus:

  • A bachelor of science or engineering degree (mechanical engineering is preferred).
  • A minimum of 3 years’ experience in a regulated industry, preferably in biotechnology.
  • Working knowledge of risk management process (e.g., ISO 14971) and hands-on experience with risk management tools (Failure Mode and Effect Analysis, Fault Tree Analysis, etc.).
  • Knowledge of probability and statistics related to risk management.
  • Excellent written and verbal communication and technical documentation skills.
  • Strong analytical and interpersonal skills.
  • Excellent mechanical aptitude and ability to come up to speed quickly on complex subject matter.
  • Flexible and adaptable to meet the needs of varying production schedules, and to take on additional responsibilities as appropriate.

Why work at Kardium?

We know you are looking for a meaningful career. We can offer you that, and more:

  • Every day you know you are making a difference by helping treat a condition that debilitates millions of people worldwide.
  • A great working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology.
  • An engaged leadership team who believes in mentoring and growing employees’ careers.
  • Supportive colleagues and plenty of fun social events to encourage employee interactions.
  • And our employees think we are great too – check out Glassdoor to learn more!

How to apply…

If this position appeals to you, apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “157 Mechanical Risk Management Engineer” in the subject line.


Software and Systems Test Engineer

Your opportunity…

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. In this role, you will gain hands-on experience in the development and commercialization of complex and leading-edge medical devices.

What you’ll be doing…

You will engage in activities such as:

  • Execute software and systems verification and validation tests
  • Draft regulatory-facing test protocols and test reports
  • Assist in creating the verification and validation strategy for in-house software and systems
  • Provide guidance to the design team to ensure that design specifications and requirements are adequately written to support verification activities
  • Become familiar with, and stay current on, relevant medical device software standards and regulations
  • Contribute to design, development, and implementation of software test automation

What you bring to the team…

Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable. You are suited to our approach and possess these attributes:

  • Bachelor’s degree in engineering or computer science
  • Minimum 2 years of experience with software verification and validation testing
  • Experience with writing specifications, test protocols, and test reports
  • Keen interest in software test automation; experience using test automation tools and frameworks such as Robot Framework and Sikuli is an asset
  • Proficiency in Python or other scripting languages
  • Practical knowledge of medical device regulatory requirements and standards such as IEC 60601 and ISO 62304 is preferred
  • Excellent communication and documentation skills
  • Positive and proactive attitude with the ability to execute tasks with an appropriate level of independence
  • Enthusiastic about seeking innovative solutions to unforeseen challenges
  • Flexibility and adaptability to take on additional responsibilities as appropriate

Why work at Kardium?

Working at Kardium provides:

  • A positive impact every day helping treat a condition that debilitates millions worldwide
  • The ability to be involved in the development of a high-complexity medical device
  • A great working environment with opportunities to develop your skills and knowledge
  • An engaged leadership team who believes in mentoring and career growth
  • Supportive colleagues and fun social events to foster teamwork
  • Competitive compensation, including equity participation

How to apply…

If this position appeals to you, apply today by sending your résumé and cover letter to jobs@kardium.com. Please use “158 Software and Systems Test Engineer” as the subject line of your email. And if you are a recent grad, please attach your most recent transcripts.