Careers

Kardium is developing a medical device that will revolutionize the treatment of atrial fibrillation.

We have built an exceptional team with expertise in medicine, business, engineering, 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.

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

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

 

 

 

 

 

 

 


Current Opportunities

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

Quality Control Technician

Quality Assurance Specialist

Logistics and Trade Compliance Manager

Quality Engineer

Electronics Engineer (General)

Mechanical Designer

Regulatory Affairs Specialist

Software Engineer


Production Technician

Kardium is looking for talented and driven production technicians to join our manufacturing team in a permanent capacity. The technician will 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

To apply for this position, please send a cover letter and résumé to jobs@kardium.com using “071 Production Technician” as the subject line.


Quality Control Technician

As a member of the Quality Assurance function, the Quality Control Technician will have direct responsibility for daily quality control activities at Kardium to support product release.

Responsibilities

The Quality Control Technician will be responsible for:

  • Sampling, inspection, and measurement of incoming raw materials according to established material and component specifications.
  • Sampling, inspection, and measurement of in-process and finished devices according to applicable quality control specifications and procedures.
  • Formal reporting of inspection and measurement results.
  • Initiation of non-conformity reports (NCR).
  • Cleaning, maintenance, and calibration of measuring equipment.

Education and Experience

  • Associate degree or diploma in a technical field, or equivalent combination of education, technical training, and/or related experience.
  • A minimum of 5 years of quality control experience in a biotech field.
  • Excellent working knowledge of Geometric Dimensioning & Tolerancing (GD&T) principles and terminology.
  • Good understanding of ISO 13485, cGMPs, and regulatory requirements pertaining to quality control.
  • Experience and proficiency with statistical analysis applications an asset.
  • Working knowledge of medical device cGMPs, standards, and regulatory requirements pertaining to quality control.

Required Skills

  • Ability to interpret mechanical drawings to understand specified dimensional and functional characteristics to be measured, tested, or inspected.
  • Proficiency with standard measurement tools/systems (calipers, micrometers, height gauges, dial indicators, force gauges, etc.).
  • Demonstrated proficiency with advanced measurement tools/systems such as vision-based systems and CMMs an asset.
  • Ability to appropriately interpret and follow detailed inspection and test procedures, and to document results accurately.
  • Effective written and verbal communication and technical documentation skills.
  • Ability to conduct MSA, such as Gauge R&R studies, an asset.
  • Flexible and adaptable to take on additional responsibilities as appropriate.

To apply for this position, please send a cover letter and résumé to jobs@kardium.com using “081 Quality Control Technician” as the subject line.


Quality Assurance Specialist

Position Posted Date: June 8, 2017

Term: Permanent, full-time

Compensation: $51,500 or higher depending on education and experience, plus extended health and participation in equity through a stock option plan

Job Duties

Quality Assurance (QA) support to Manufacturing team:

  • Conducting the QA review of production Device Master Record documentation, including work instructions and traveller templates
  • Conducting the QA review of production documentation pertaining to quality issues, including nonconformities, deviation permits and reworks
  • Executing the QA release of incoming and in-process goods
  • Conducting the QA review of Device History Records (DHRs) to support finished goods release
  • Ensuring adequate material status labelling throughout production
  • Root cause investigation support (e.g., targeted DHR review)

QA support to Engineering team:

  • Conducting the QA review of Device History File documentation, such as test protocols, test reports, investigation reports, engineering change requests, etc.
  • Conducting the QA review of Process Validation and Software Tool documentation, such as test protocols, test reports, etc.
  • Participate in the QA coordination of Engineering Change Request approval, implementation and closure activities

Quality Management System support:

  • Participating in Kardium’s Internal Audit program as needed
  • Performing Document Control tasks such as documentation completeness verification and release of approved documents
  • Performing any other QA tasks as required

Skills

  • Strong analytical skills and critical thinking
  • Effective written and verbal communication and technical documentation skills
  • Excellent computer skills (MS Office, Excel)
  • Able to operate independently with minimal direction
  • Organized and detail-oriented
  • Excellent interpersonal skills including the ability to resolve conflict with poise, diplomacy and tact.
  • Ability to work effectively as part of a team and collaborate with staff at all levels
  • Flexible and adaptable to take on additional responsibilities as appropriate

Education and Work Experience

  • Bachelor of Science degree in a technical discipline (e.g. engineering, physics, etc.).
  • At least 3 years’ QA experience in a biotech manufacturing environment. Experience in QMS planning and implementation an asset
  • Strong, in-depth, working knowledge of ISO 13485, FDA QSR and QMS requirements of the European MDD
  • Experience with electronic document and electronic record management systems

Application Process

To apply for this position, please send a cover letter and résumé to jobs@kardium.com using “082 Quality Assurance Specialist” as the subject line.


Logistics and Trade Compliance Manager

The Logistics and Compliance Manager will provide the leadership and support to deliver a world-class logistics system for an advanced cardiac ablation system. The Manager will develop a distribution logistics strategy that meets customer delivery expectations and regulatory requirements in the most cost-effective manner. Seamless integration between shipping, receiving, and all other Kardium operations processes is a key objective of the role. The successful candidate will demonstrate superior leadership skills in logistics acumen, supplier relationship management, project management, and team building. The role is a full-time, permanent position.

Responsibilities

  • Manage and lead all shipping, distribution logistics, trade compliance, and receiving department resources and activities
  • Evaluate existing transport and customs brokerage arrangements and implement a strategy to provide the most cost effective end-to-end supply chain logistics solution
  • Develop and drive implementation of Kardium’s global distribution logistics strategy
  • Source, qualify, and manage performance of all logistics providers and engage in continuous improvement both internally and externally to maximize supply chain value and sustainability
  • Ensure accuracy of import and export declarations, as well as compliance with all trade and regulatory requirements
  • Verify product qualification for free trade agreements and ensure Kardium takes advantage of such agreements
  • Manage all receiving activities for incoming goods
  • Manage the organization and efficiency of the shipping and receiving areas
  • Develop and manage standard operating procedures for all logistics, trade compliance, and receiving activities
  • Proactively identify need for resources and lead hiring, training, and retention of top talent

Experience and Qualifications

  • Minimum 5 years’ experience in a logistics management role covering transportation, operations management, distribution logistics, and trade compliance
  • Minimum 3-5 years’ of team management and leadership experience
  • Experience sourcing, qualifying, and developing 3PL providers
  • Proven track record implementing continuous improvement programs and driving ongoing cost reduction
  • Bachelor degree in supply chain management, logistics, engineering, or a related field
  • Experience working in regulated environments such as ISO 13485 and/or AS9100 is desirable

Personal Attributes

  • Superior organizational and time management skills
  • Ability to prioritize and manage multiple, competing deliverables effectively in a fast paced, schedule-driven environment
  • Strong interpersonal skills with the ability to grow relationships across multiple functions and at all levels of the organization
  • Ability to communicate effectively at all levels both internally and externally
  • Ability to travel worldwide as required
  • Strong desire to contribute positively in a stressful and demanding, but also motivating, energetic, and fun, working environment

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “086 Logistics and Trade Compliance Manager” in the subject line.


Quality Engineer

Kardium has an exciting opportunity for an experienced and motivated Quality Engineer to join our world-class team in the development of Kardium’s novel catheter for percutaneous treatment of atrial fibrillation.

As part of the Quality Assurance team, and in close cooperation with the Engineering and Manufacturing teams, the Quality Engineer will be responsible for quality planning and implementation efforts to support successful new product launches and ongoing production. The position offers an opportunity to plan aspects of quality assurance, and a chance to be involved in hands-on quality engineering of cutting-edge medical devices.

The role will evolve over the product life cycle with the initial focus on planning for, and ensuring consistent quality of devices produced for pre-clinical and early clinical testing, then shifting to manufacturing and operations support in the later stages of the commercialization process. The successful candidate will apply their ISO 13485 and US FDA QSR experience and their quality engineering knowledge to assist the Quality Assurance, Engineering, and Manufacturing teams in the identification and resolution of quality issues.

Responsibilities

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

  • Support the development and implementation of Control Plans
  • Collaborate with the Risk Management Team in the conduct and documentation of process risk analyses
  • Support the planning and implementation of process capability and stability assessment and monitoring systems
  • Assist 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:

  • Support production change control activities, including maintenance of Control Plans
  • Participate in the review of nonconforming product and materials as required
  • Monitor and evaluate product quality, and process stability and capability
  • Based on monitored data, identify trends, and provide solutions for corrections or improvements
  • Work 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
  • Participate in the assessment of post-market surveillance feedback and implement any resulting corrective and preventive actions, and necessary improvements to process controls

Experience and Qualifications

  • 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
  • Sound knowledge of statistics, SPC, FMEA, and process capability
  • Experience working in environments compliant with ISO 13485 and US FDA Quality System Regulation

Personal Attributes

  • Excellent written and verbal communication and technical documentation skills
  • Strong interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization
  • Flexible and adaptable to take on additional responsibilities as appropriate

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “087 Quality Engineer” in the subject line.


Electronics Engineer (General)

About the Position

Kardium is looking for an electronics engineer (general) to join our medical device development team. The successful candidate will be responsible for developing and performing testing of components of a tissue ablation system used to treat atrial fibrillation.

We are looking for an individual who is eager and interested in taking on a diverse set of challenges including: designing analog and digital circuits, investigating technical failures, and performing data analysis. The successful candidate will be familiar with the basics of electrical engineering and will be able to complete electronics design tasks under guidance. The successful candidate will demonstrate the ability and potential to eventually become a fully independent senior engineer.

Responsibilities

  • 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.

Education and Experience

  • 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.

Personal Attributes

  • 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.
  • Good interpersonal skills, including: maturity, teamwork, respect, courtesy, tact, and discretion.

The successful candidate will preferably have:

  • 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?

  • Work on medical devices that will improve people’s lives.
  • Work with smart, friendly, and helpful people.
  • Competitive compensation, including equity participation.

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, using “088 Electronics Engineer (General)” as the subject line. Indicate in your cover letter why you are interested in Kardium and why you are interested in this specific position.


Mechanical Designer

Kardium is looking for two (2) talented and driven mechanical designers to join the medical development team. The successful candidates will work in a multi-disciplinary environment with other members of the engineering and research teams in the conceptual development, detailed design, verification and validation testing of percutaneously delivered medical devices.

Essential abilities of the successful candidates include strong hands-on and analytical skills as well as the ability to transform concepts to final design.

Responsibilities may include:

  • Establishing design specifications required to meet overall product requirements
  • Building proof of concept models to quickly and efficiently verify design ideas
  • Transforming conceptual designs to working prototypes
  • Producing prototypes for in-vitro and in-vivo testing using in-house manufacturing capabilities
  • Designing and building jigs and fixtures required for production
  • Ensuring smooth transition of design to manufacturing by supporting risk management, verification testing, and training of manufacturing staff
  • Contributing to required documentation for outsourcing components as well as regulatory submissions
  • Occasional travel within and outside North America

Education

  • B.Sc. in Mechanical Engineering, or equivalent

Experience

  • Previous practical engineering experience in a product development environment
  • Strong mechanical aptitude and analytical skills
  • Experience with precision mechanics
  • Exposure to different manufacturing techniques
  • Familiarity with machine shop tools, and parametric modeling software (Solidworks)

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

Desired Assets

  • Prior engineering experience in bringing a product to market with high volumes
  • Familiarity with the design and testing requirements of medical devices
  • Prior experience in setup and execution of failure mode effect analysis (FMEA)
  • Specific experience with Solidworks and CAM software

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “092 Mechanical Designer” in the subject line. With your application, please include either a copy of your most recent transcript or your GPA for your last year of formal studies.


Regulatory Affairs Specialist

As a Regulatory Affairs (RA) Specialist, you will be responsible for product submissions, licence renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.

Responsibilities

  • Represent regulatory affairs on product development project teams to ensure all regulatory requirements are met throughout the development process
  • Create and maintain product EU technical files and design dossiers
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners; advise on the submission strategy
  • Timely compilation of materials for, and processing as required of, licence renewals, updates, and registrations
  • Interact with regulatory agencies as required for the processing of submissions, regulatory reports, and any other regulatory actions
  • Maintain regulatory files/database and chronologies in adequate order; establish and maintain systems for tracking submissions, and changes thereof, sent to agencies or partners
  • Review labeling and labels for compliance with regulatory requirements
  • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
  • Actively participate in evaluation of regulatory compliance of changes to documents, products, processes, and test methods, and define the requirements for regulatory reporting of such changes
  • Provide regulatory reviews of customer complaints and define the regulatory report-ability
  • Maintain current knowledge of EU, FDA, and international regulation, guidance, and standards applicable to company products
  • Participate in research of regulatory issues and disseminate regulatory information to Production, QA, QC, and Engineering teams and senior management as required
  • Coordinate the outsourcing of projects to, and collaborate with, regulatory affairs consultants as required

Experience and Qualifications

  • Bachelor of science or engineering degree
  • Minimum of 5 years of relevant regulatory affairs experience
  • Experience with class II devices is mandatory, and with class III devices is preferable
  • 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 skills
  • Strong organizational and project management skills, including the ability to prioritize project tasks
  • Quick learner and team player who thrives in a fast-paced environment
  • 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

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “093 Regulatory Affairs Specialist” in the subject line.


Software Engineer

Kardium has a unique opportunity for a Software Engineer who is interested in pursuing a career in the medical device industry. This position involves designing, coding, testing, and maintaining various software tools used across the company to support our research and manufacturing data management, enterprise resource planning, and quality management systems.

Responsibilities

  • Design and implement internal software tools to integrate data from ERP and other third party systems.
  • Extend functionality of existing manufacturing and quality management systems using their APIs and databases.
  • Support automation of data collection from manufacturing and QC processes.
  • Provide software support for QA, supply chain, and manufacturing operations.
  • Participate in requirements analysis during tool planning.

Education and Experience

  • Experience creating multi-tier desktop applications (graphical user interface, business logic, data access).
  • Advanced object-oriented programming skills, typically with Java, C#, or C++.
  • Experience with relational databases such as SQL Server, MySQL, or Oracle.
  • Familiarity with issue tracking systems, such as FogBugz, Jira, or Bugzilla.
  • Experience with source repositories, such as Perforce, CVS, Git, or Subversion.
  • Bachelor’s degree or higher in software engineering or equivalent.
  • At least 2 years’ experience in software development, ideally in a regulated environment.

The successful candidate will preferably have:

  • Experience developing Windows applications using .NET framework or equivalent.
  • Experience with GUI frameworks (WinForms, WPF, or Swing).
  • Proven ability to learn and use third party APIs and libraries.
  • Familiarity with complex database table joins, views, stored procedures, indexes.
  • Experience with scripting languages such as Python or Perl.

Personal Attributes

  • Have excellent communication skills.
  • Have a history of success working in a team setting.
  • Have a keen desire to help produce high quality code.
  • Be highly proactive and able to execute tasks with minimal instruction and guidance.
  • Be enthusiastic about finding innovative solutions to unforeseen challenges.

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “095 Software Engineer” in the subject line.


 

Visit us on TwitterVisit us on FacebookVisit us on GooglePlusVisit us on Linkedin