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

Glassdoor

Google


Current openings

Production Technician
Quality Control Technician
Quality Control Manager
Mechanical Verification Engineer
Mechanical Verification Technician
Electrical-System Risk Management Engineer
Software and Systems Test Engineer
Software Engineer
Biomedical Research Engineer
Equipment Maintenance Technician
New Product Introduction Manager


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.


            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.


                Quality Control Manager

                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.

                In this critical role, you have the direct responsibility for Kardium’s quality control activities to support our product release. Specifically, you will push forward our quality program to significantly improve efficiencies and ensure compliance to all regulatory requirements. You will work collaboratively with the engineering and manufacturing teams to analyze new developments to determine the appropriate balance of quality and efficiency. The quality team’s daily activities are overseen by the Quality Control Planner, allowing you the opportunity to investigate and evaluate complex problems and apply your in-depth knowledge to create effective solutions.

                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 a 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
                • Working collaboratively with the Quality Control Planner to coordinate quality control activities, such as incoming and in-process inspections
                • Coordinating quality control support for various research and development activities, as well as, 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
                • Overseeing the team’s performance management activities, such as training activities and team development

                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 minimum of 5 years’ quality control and mechanical engineering experience in a regulated manufacturing environment where you demonstrated your high attention to detail and rigour and where you gained experience managing the quality control team and operations
                • Bachelor’s degree in engineering, preferably mechanical engineering, or other applied science, or equivalent
                • 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 preferably gained from managing teams and working within a collaborative environment, coupled with an interest in developing people’s careers
                • Strong analytical skills and critical thinking honed from investigating and evaluating complex issues
                • 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…

                Apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “152 Quality Control Manager” in the subject line.

                Thanks in advance for your interest in working at Kardium!


                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.


                  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.


                  Software Engineer

                  Your opportunity…

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

                  As a part of our team, your challenge is to develop innovative, user-friendly software features for our revolutionary Globe® Mapping and Ablation System. You will work collaboratively within the software team to develop high quality Java and C/C++ code for our new product features and you will have the opportunity to directly influence our product development through our software engineering practices.

                  What you’ll be doing…

                  You will help implement new features and improve usability and performance of existing functionality. In partnership with your team, you will focus on feature development, optimization, code quality, UI/UX design, and support tools. In addition, you may participate in:

                  • Requirements and design specification
                  • Investigations of reported anomalies
                  • Code inspections
                  • Design, specification, and risk reviews
                  • TDD/unit testing
                  • Test platform and integration test development
                  • Professional skills development, site visits, and/or usability testing

                  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 love of coding, where through your 5 to 10 years of experience you have gained advanced programming skills in any object-oriented language such as C++, Java or C#
                  • A bachelor’s degree in computer science or engineering
                  • Proven ability to be a valued contributor in a disciplined, software development process
                  • Strong analytical and problem solving skills
                  • Well-developed written and verbal technical communication skills
                  • The willingness and ability to take on additional responsibilities as appropriate
                  • And experience with one or more of:
                    • Basic engineering such as electronics, signal processing, thermodynamics, control theory, UI/UX design, and/or GUI development
                    • Software development in the medical device or other regulated industry
                    • 3D graphics applications using OGL
                    • Embedded, real-time applications
                    • Algorithmic and system optimization to drive ever better responsiveness for our computationally intensive 3D visualizations

                  What do you get out of this?

                  A meaningful career working with a truly innovative technology and an ambitious team, combined with:

                  • Knowing every day you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
                  • A great working environment with opportunities to develop your skills and knowledge
                  • Opportunity to extend your knowledge beyond software development by interacting with other team members in a multi-disciplinary environment that includes electronics and mechanical engineers, biologists, and specialists in human factors, clinical and regulatory affairs
                  • An engaged leadership team who believes in mentoring and growing employees’ careers
                  • Supportive and fun colleagues with plenty of social events to encourage people connections
                  • And our employees think we are great too – check out Glassdoor to learn more

                  How to apply…

                  If this position tweaks your interest, apply today! Please send your cover letter and résumé to jobs@kardium.com using “160 Software Engineer” as the subject line.


                    Biomedical Research Engineer

                    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 minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

                    As our Biomedical Research Engineer, you join the research team, which is unique as it bridges the domains of engineering and medicine to drive developments related to ablations, electrophysiology, mapping, algorithms and other contributing fields to clinical safety and efficacy. You would have the opportunity to bring your creative and innovative ideas to help Kardium achieve its goal of helping improve people’s lives.

                    What you’ll do…

                    • Applying scientific investigation methods to drive product innovations in design and analysis algorithms
                    • Systematically analyzing large multivariate data sets of electrophysiological and procedural data
                    • Completing algorithm design and numerical analysis for contact assessment, electrophysiology, and ablation-related design improvements
                    • Conducting literature search and review
                    • Fulfilling procedural data review and investigation
                    • Creating technical documentation of analyses, experiments, and results
                    • Designing and/or performing bench tests experiments as needed

                    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:

                    • Either a bachelor or graduate degree in engineering, biophysics, or equivalent field addressing quantitative biology and ideally, you have experience within the medical device industry
                    • A solid understanding of the principles of experimental design
                    • Extensive MATLAB programming experience, as well as experience with other data analysis languages, such as R, Python or Java
                    • An excellent understanding of multivariate and time-series statistical analysis methods
                    • The ability to perform finite element analysis with COMSOL
                    • Hands-on experience broadly surveying or performing a focused search of scientific literature with the ability to apply critical thinking to correctly interpret the published ‘state of the art’
                    • The demonstrated ability to interpret results and translate them into actionable recommendations
                    • The aptitude for working independently and balancing multiple tasks while maintaining your attention to detail
                    • Effective written and verbal communication and technical documentation skills
                    • Highly beneficial is an in-depth understanding of electrophysiology and the biophysics of cardiac conduction and ablation

                    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…

                    Apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “162 Biomedical Research Engineer” in the subject line.

                    Thanks in advance for your interest in working at Kardium!


                    Equipment Maintenance Technician

                    About the Job

                    Kardium has a unique opportunity for an experienced Equipment Maintenance Technician. As a member of the Manufacturing team, the Equipment Maintenance Technician will be responsible for managing the maintenance and calibration all manufacturing equipment used in the production of the Globe catheter for the treatment of atrial fibrillation. This position will report to the Manufacturing Operations Engineer.

                    Responsibilities

                    Equipment Maintenance:

                    • Generate equipment maintenance schedule
                    • Working with process engineering team, develop maintenance procedures and schedule for custom-built and third-party manufacturing equipment
                    • Complete wear-and-tear inspections on process equipment
                    • Perform mechanical and electrical maintenance tasks as per manufacturing equipment schedule
                    • Respond in a timely manner to equipment breakdowns and repair as necessary
                    • Training of production technicians on day-to-day care of process equipment
                    • Using statistical analysis techniques, develop preventative maintenance (PM) plans for both custom and third-party process equipment
                    • Management of a spare parts inventory system and stocking plan based on anticipated failure rates

                    Equipment Calibrations:

                    • Manage entire set of production gauges and measurement equipment to ensure calibrations are performed in a timely manner
                    • Schedule internal maintenance for manufacturing measurement and process equipment to ensure they are calibrated on a prescribed schedule
                    • Manage and send out RMA equipment for calibration as required
                    • Send out equipment to third-party calibration labs, and compile calibration documentation in an accessible format
                    • Perform measurement verification tests on equipment

                    Facilities Management:

                    • Perform cleanroom cleanliness monitoring activities
                    • Manage and maintain cleanroom HVAC systems
                    • Review and optimize facility energy use

                    Documentation Management:

                    • Assist in the development and execution of Installation Qualifications (IQs) for new and revised equipment that will be used in manufacturing operations
                    • When required, assist in the execution of equipment re-validation when modifications are made to the process
                    • Maintain equipment database for all manufacturing equipment, tracking all required pertinent information (maintenance events, equipment location, status, etc.)

                    Performance Metric Reporting:

                    • Develop a system for measuring equipment downtime and other performance metrics, as well as a reporting system to summarize for various stakeholders

                    Equipment Event Planning and Coordination:

                    • Coordinate and plan cleanroom cleaning activities
                    • Implement changes to equipment
                    • Implement jig and equipment software and firmware updates
                    • Coordinate equipment maintenance down time with production and testing teams

                    Procedure Development:

                    Work closely with the quality assurance, risk, engineering, and testing teams to:

                    • Develop equipment change and qualification work flows that follow good manufacturing practices for biomedical devices
                    • Develop verification test methods for manufacturing equipment

                    Education and Experience

                    • Bachelor’s degree or technical diploma, preferably in a technical/science field, or equivalent combination of education and experience
                    • Minimum 5 years’ experience in equipment maintenance in a manufacturing environment, preferably in the biotechnology, pharmaceutical, diagnostics, or medical devices industry
                    • Demonstrated ability to manage multiple projects with a high degree of accuracy and timeliness
                    • Experience working in a cleanroom environment is desirable
                    • Experience working in the biomedical device or pharmaceutical industry is desirable

                    Requirements and Skills

                    • Strong analytical skills and critical thinking
                    • Knowledge of statistical techniques, specifically around the development of PM programs for manufacturing equipment
                    • Effective written and verbal communication and technical documentation skills
                    • Able to operate independently with minimal direction
                    • Detail-oriented
                    • Excellent interpersonal skills
                    • Flexible and able to take on additional responsibilities as appropriate

                    How to Apply

                    To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “163 Equipment Maintenance Technician” in the subject line.


                    New Product Introduction Manager

                    Kardium has a unique opportunity for an experienced New Product Introduction (NPI) Manager. As a member of the Manufacturing team, the NPI Manager will be responsible for coordinating the transfer to production of product design and process changes and for ensuring that changes are implemented in an organized and timely manner. This position will report to the Manufacturing Team Lead.

                    Duties and Responsibilities

                    The NPI Manager will be responsible for the following areas:

                    Change management:

                    • Ensure, in collaboration with QA and Engineering, that the appropriate pre-production design activities, including all necessary design reviews, are completed, documented, and approved by the relevant functions prior to the transfer to production of changes to product design and manufacturing processes
                    • Ensure, in collaboration with Engineering, Supply Chain, Manufacturing, and Quality Assurance (QA), that action items pertaining to Engineering Change Orders (ECOs) are completed according to scheduled commitment dates
                    • Drive all product and process change implementations in accordance with priority set by the Manufacturing, Engineering, and Supply Chain teams
                    • Create and coordinate cross-functional project teams for major product and process changes to ensure that change implementation timelines are achieved
                    • Ensure that production build requirements from engineering and testing teams related to change implementations are communicated to Production Planning (e.g. PV and DVT sample builds); provide input for other testing-related production build requirements as needed (e.g. process monitoring, cleanliness monitoring, etc.)
                    • Collaborate with QA and Testing to ensure that appropriate verification and validation activities required for the implementation of a change are completed, documented, and approved by the relevant functions to support the release of product

                    Change control analysis and reporting:

                    • Track pertinent information relating to change control, to permit efficient retrieval and audit of information
                    • Develop and maintain metrics on the effectiveness of change implementation activities
                    • Develop a dashboard status of manufacturing processes and generate periodic reports for senior management and the Change Control Review Board; ensure Production Planning is up-to-date on manufacturing process status

                    Change control system maintenance and improvement:

                    • Develop a business process for prioritization of Engineering Change Requests and ensure that the process is implemented and adhered to across all functional areas of the company
                    • Maintain Standard Operating Procedures (SOPs) related to change control activities, and provide training on any revised procedures
                    • Assist with the planning and execution of validation of software tools used to support change control processes

                    Experience and Qualifications

                    • Bachelor degree in a technical or science field
                    • Minimum 5 years’ experience in plant operation and change control management in a regulated manufacturing environment, preferably in the biotechnology, pharmaceutical, diagnostics, or medical devices industry
                    • Strong, practical knowledge of R&D, NPI, supply chain, and quality control
                    • Practical knowledge of worldwide cGMPs, regulatory requirements, and quality management systems for medical devices, in particular pertaining to change control
                    • Demonstrated ability to manage multiple projects with a high degree of accuracy and timeliness

                    Skills and Attributes

                    • Ability to communicate project timelines and priorities to a wide range of audiences
                    • Strong analytical skills and critical thinking
                    • Able to operate independently with minimal direction
                    • Ability to shift priorities as needed in a fast-changing development environment
                    • Detail-oriented
                    • Excellent interpersonal skills, with the ability to work cross-functionally within an 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 “164 New Product Introduction Manager” in the subject line.