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

Production Technician
Quality Assurance Specialist
New Product Introduction Manager
Mechanical Designer
Electrical Production Engineer
Mechanical Verification Engineer
Regulatory Affairs Specialist
Chemical Process Engineer
Senior Electrical Verification 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.


    Quality Assurance Specialist

    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.

    Take the next step and grow your career as our Quality Assurance (QA) Specialist. In this role, you provide direct QA support to our manufacturing and engineering teams and contribute to the effective operation of Kardium’s Quality Management System (QMS).

    What you’ll do…

    • Working collaboratively with our manufacturing team to conduct the QA review of production Device Master Record documentation, including work instructions and traveller templates, and reviewing production documentation to resolve any quality issues, including non-conformities, 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
    • Root cause investigations (e.g. targeted DHR review)
    • Conducting the QA review of equipment documentation
    • Working closely with the engineering team to conduct the QA review of the verification and validation documentation, such as test protocols, test reports, investigation reports, and engineering change requests
    • Conducting and managing the QA review of process validation and software tool documentation, such as test protocols and test reports
    • Using your judgment within undefined practices and procedures that may be incomplete or complex and bring gaps to management’s attention
    • Participating in the QA coordination of change control activities
    • Other QMS support, such as contributing to Kardium’s internal audit program
    • Performing document control tasks such as documentation completeness verification and release of approved documents

    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 3 years’ quality assurance experience in a manufacturing environment, ideally in the biotech industry where you have preferably gained experience in QMS planning and implementation, including the documentation required for a product release such as Certificates of Conformances and Device History Records
    • Bachelor of science degree in a technical discipline (e.g. engineering, physics, etc.)
    • Hands-on experience with QA review and approval of:
      • facility and equipment qualification protocols and final reports
      • design verification and validation protocols and final reports
      • cleaning validation protocols and final reports, and
      • analytical test method validation
    • Ideally in-depth knowledge of ISO 13485, FDA QSR, and QMS requirements of the European MDD
    • Proficiency with electronic document and electronic record management systems
    • Strong analytical skills and critical thinking that can be applied to understanding and analyzing technical documents, processes, regulations, industry standards, and procedures
    • Well-developed written and verbal communication and technical documentation skills
    • Demonstrated ability to operate independently with minimal direction, coupled with an organized and detail-oriented approach to track and follow-up with the outstanding actions of your internal customers
    • Excellent interpersonal skills, including the ability to resolve conflict with diplomacy and tact
    • The flexibility and adaptability to take on additional responsibilities as needed to achieve the team’s goals
    • The ability to represent compliance requirements for document review and product release to internal stakeholders.

    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 “161 QA Specialist” in the subject line. Please note only candidates who are currently legally authorized to work in Canada will be considered for this position.

    Thanks in advance for your interest in working at Kardium!


          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.


            Mechanical Designer

            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 conditions affecting the quality of life.

            We are excited to add a Mechanical Designer to our team.

            In this role, you 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. Your hands-on mechanical design abilities, combined with your well-developed analytical skills, will allow you to succeed as Kardium’s Mechanical Designer.

            What you’ll do

            • Working collaboratively with the team you will establish design specifications required to meet overall product requirements
            • Using your hands-on skills, you will build proof of concept models to quickly and efficiently verify design ideas
            • Applying your strong mechanical aptitude to transform conceptual designs into 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 a 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
            • Travelling occasionally within and outside North America

            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’s degree or higher in mechanical engineering, or an equivalent mix of education and experience, coupled with previous practical engineering experience in a product development environment
            • Ideally, you have prior engineering experience in bringing a product to market with high volumes along with the design and testing requirements of medical devices
            • Previous on the job experience with precision mechanics and a high level of familiarity with machine shop tools, and parametric modelling software (Solidworks)
            • Exposure to different manufacturing techniques
            • Proven problem-solving abilities and attention to detail while working in a deadline-driven environment
            • Excellent written and verbal communication and technical documentation skills
            • The ability to effectively manage changing priorities and requirements

            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 “173 Mechanical Designer“ in the subject line.

            Please note, only candidates who are currently legally authorized to work in Canada will be considered for this position.

            Thanks in advance for your interest in working at Kardium!


                  Electrical Production Engineer

                  About Kardium

                  Kardium is a technology pioneer developing devices to address cardiovascular diseases. The company was founded in 2007 by a team with a track record of excellence in medicine, business, and engineering. Focused on building a world-class, internationally dominant medical device company, we believe in having lots of fun while working hard. We hire top individuals who are strong team players and trust them to make the right decisions to achieve our goals. In the BC Business “2010 Best Companies to Work for in BC” survey, Kardium was voted the #1 Life Sciences and Health Services Companies, and the #5 company overall.

                  About the Job

                  Kardium has a unique opportunity for an experienced Electrical Production Engineer. As a member of the Manufacturing team, the Electrical Production Engineer will be responsible for the organization of the process flow in manufacturing, the assessment and dispositioning process for non-conforming material in the manufacturing environment, working with the electrical engineering team in prioritizing and implementing product and process improvements, and providing DFM inputs into product enhancements and future products. This position will report to the Manufacturing Manager.

                  Responsibilities

                  The Electrical Production Engineer will be responsible for the following:

                  Production Support Activities

                  • According to Kardium’s QMS, ensure that appropriate documentation is in place to ensure that parts have been released and dispositioned appropriately to meet production plan
                  • In coordination with Production Technicians and the Engineering, Risk, and QA teams, drive generation and closure of nonconformity reports for both incoming and WIP parts
                  • Develop manufacturing documentation (process flow diagrams, work instructions, travelers) for new and existing manufacturing processes
                  • Ensure compliance to process controls and Kardium’s medical device quality system in production
                  • Act as first line of support for troubleshooting of quality issues, particularly in relation to PCB assemblies
                  • Develop training plans and execute training for Production Technicians

                  Manufacturing Area Organizational Optimization

                  • Analyze manufacturing process layout to maximize efficiency through lean manufacturing methodologies
                  • In coordination with the Production Manager and Supervisors, as well as other teams as applicable, ensure the Production Technicians are provided with the parts, tools, training and other necessary documentation to carry out work orders in a timely and efficient manner
                  • In coordination with the Production Manager and Supervisors, drive 5S organization activities in the production environment
                  • Develop and drive implementation of WIP and finished good product storage within the manufacturing environment
                  • Act as primary point of contact for regulatory factory audits related to electrical production area

                  Implementation of Process Improvements

                  • Based on daily interaction with Production Manager, Supervisors, and Production Technicians, provide regular feedback to the planning and design engineering teams on process bottlenecks and areas for potential improvement; assist in implementation, where applicable
                  • Work with the Engineering team to resolve root causes for ongoing quality issues for various manufacturing processes, and drive implementation of solutions, where applicable

                  New Product and Process Development

                  • Liaise with the Engineering and Planning teams to roll out product design and process changes in an organized and controlled manner into production, following Kardium’s change control process
                  • Provide input into product design for new and next-generation product to ensure design is optimized for manufacturability
                  • Work with Process Engineering team to develop suitable processes for next-generation products

                  Education and Experience

                  • Bachelor’s degree in electrical or industrial engineering
                  • Minimum 5 years’ experience in plant operation and production engineering 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
                  • Excellent ability to troubleshoot and problem-solve, and to lead root-cause analysis of quality issues in a manufacturing environment
                  • Strong experience with process value stream mapping, DFM, and change control management
                  • Experience with and solid understanding of statistical process controls, lean manufacturing, six-sigma implementation is preferred
                  • Practical knowledge of worldwide cGMPs, regulatory requirements, and quality management systems for medical devices
                  • Demonstrated ability to manage multiple projects with a high degree of accuracy and timeliness

                  Preferred Requirements and Skills

                  • Strong analytical skills and critical thinking
                  • Mechanical aptitude related to parts assembly and tolerancing
                  • Effective written and verbal communication and technical documentation skills
                  • Able to operate independently with minimal direction
                  • Detail-oriented
                  • Excellent interpersonal skills
                  • Flexible and adaptable 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 “186 Electrical Production Engineer” in the subject line.

                  Please note, only candidates who are currently legally authorized to work in Canada will be considered for this position.


                  Mechanical Verification Engineer

                  Your opportunity…

                  By joining the Kardium team, you can help make a difference in the lives of millions around the world. We are commercializing 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 conditions affecting patient quality of life.

                  As a part of the Testing team, you will apply your well-developed analytical skills and knowledge of mechanical systems to ensure that our Globe® Mapping and Ablation System is both safe and effective. Working closely with a collaborative and dedicated team, you’ll have opportunities to bring innovative and highly complex medical devices to market.

                  What you’ll do…

                  You will design, plan, and execute testing activities to evaluate product performance. Specifically, you may:

                  • Develop test methods to evaluate product performance and manufacturing process capability
                  • Design and fabricate test jigs using CAD and CAM software
                  • Develop expertise in relevant medical device standards and industry accepted test methods
                  • Drive continuous improvement of company procedures as they pertain to verification and validation
                  • Collaborate with company stakeholders to initiate and resolve root cause 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 testing or design experience in the medical device industry, or 5 years of hands-on experience with mechanical/hardware product testing
                  • Strong attention to detail with a sound ability to manage multiple tasks accurately and in a timely manner
                  • Practical knowledge of mechanical systems, experimental design, and statistics as applied to verification and validation testing
                  • Excellent verbal communication, as well as exceptional written technical documentation skills

                  Why work at Kardium?

                  We know you’re looking for a meaningful career. Here at Kardium, we enjoy:

                  • The opportunity to advance medical technology and improve the lives of patients
                  • A great working environment with opportunities to develop skills and knowledge
                  • An engaged leadership team who believes in mentoring and career growth
                  • Supportive colleagues and fun social events to foster teamwork
                  • And our employees think we are great too – check out Glassdoor to learn more!

                  How to apply…

                  To apply for this position, please send your cover letter and résumé to jobs@kardium.com using “187 Mechanical Verification Engineer” as the subject line.

                  Please note, only candidates who are currently legally authorized to work in Canada will be considered for this position.


                  Regulatory Affairs Specialist

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

                  As a Regulatory Affairs (RA) Specialist, you will work with the RA Team to bring innovative and highly complex medical devices to the market and maintain their regulatory compliance. The role will involve coordinating submissions for market authorizations, clinical investigations, and product renewals, as well as providing regulatory input on the development of products and processes internally. This position will report to the RA Manager.

                  Responsibilities

                  • Provide regulatory affairs input into product development projects to ensure all regulatory requirements are met throughout the development process
                  • Create and maintain product technical files, design dossiers, and design history files
                  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
                  • Compile and process materials for license renewals, updates, and registrations
                  • Interact with regulatory agencies such as the FDA, Health Canada, and EU notified bodies as required for the processing of submissions, regulatory reports, and any other regulatory actions
                  • Assist with the implementation and maintenance of systems for tracking submissions, and changes thereof, sent to regulators and partners
                  • Maintain regulatory files, databases, and chronologies in adequate order
                  • Review marketing material, labeling, and labels for compliance with regulatory requirements
                  • 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 the regulatory reviews of customer complaints and define the regulatory reportability
                  • Conduct post-market surveillance activities and trend analysis
                  • Maintain current knowledge of EU, US, Canadian, and international regulations, guidance, and standards applicable to company products
                  • Participate in research of regulatory issues and disseminate regulatory information to Production, QA, QC, Engineering teams, and senior management as required

                  Experience & Qualifications

                  • Bachelor of science or engineering degree
                  • A minimum of 3 years of relevant regulatory affairs experience, or equivalent combination of post-graduate education and experience
                  • Experience with class II devices is mandatory, and with class III device is preferable
                  • In-depth working knowledge of European, US, Canadian, and international medical device regulatory requirements
                  • Experience with Design Controls is an asset

                  Personal Attributes

                  • Excellent written and verbal communication
                  • Excellent technical documentation skills
                  • Strong interpersonal skills
                  • Strong organizational and project management skills
                  • Quick learner and team player who thrives in a fast-paced environment with proven ability to manage multiple priorities
                  • 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

                  To apply for this position, please send your cover letter and résumé to jobs@kardium.com using “196 Regulatory Affairs Specialist” as the subject line.


                  Chemical Process Engineer

                  Kardium has a unique opportunity for an experienced Pharmaceutical Chemical Process Engineer. As a member of the Engineering team, the Chemical Process Engineer will be responsible for the development, transfer, start-up, and improvement of all chemistry-related processes at Kardium’s Burnaby production facility.

                  Responsibilities

                  The Chemical Process Engineer will be responsible for:

                  Chemical Process Development:

                  • Develop robust, scalable, validated chemical processes for combination products
                  • Characterize processes; construct and execute controlled experiment (including DOEs) and interpret results to evaluate critical process parameters and material attributes
                  • Recommend raw material requirements and work with Purchasing on vendor selection and qualification
                  • Author protocols, pharmaceutical development reports, SOPs and other technical documents, which may support regulatory filings
                  • Transfer processes, knowledge, and technologies into production.

                  Chemical Process Engineering:

                  • Determine manufacturing suites requirements such as layout, flows, classifications, and utilities requirements
                  • Assess process equipment requirements to meet demand and quality objectives
                  • Design, install, commission, and qualify new production equipment; write equipment specifications and qualification protocols and reports
                  • At clinical and commercial manufacturing scale, assess process variability, stability and capability, and suggest and implement process improvements and control strategies
                  • Identify opportunities to maximize throughput, minimize waste, and improve safety while maintaining the highest standard of quality
                  • Develop Standard Test Methods (STMs) for incoming chemical material and chemical process output testing, and plan, execute, and document STM validation as required
                  • Write Standard Operating Procedures (SOPs) and Work Instructions (WIs), and train operators and lab analysts in the new processes and STMs
                  • Ensure new production processes and STMs are compliant with Kardium’s medical device quality management system (QMS)

                  Manufacturing Engineering:

                  • Provide technical support to daily operations of chemical processes; troubleshoot processes, identify non-conformance root causes and assist in the implementation of preventive and corrective actions
                  • Develop strategies for process improvements to support manufacturing objectives for cost, quality, safety, and on-time delivery
                  • Participate in Material Review Board (MRB) meetings when required, ensuring that non-conforming materials are dispositioned efficiently

                  Experience and Qualifications

                  • Bachelor’s degree in chemical engineering
                  • Minimum 5 years’ experience in plant operation and production engineering in a regulated manufacturing environment, preferably in the pharmaceutical, diagnostics, or medical devices industry
                  • Practical knowledge of worldwide GMPs, regulatory requirements, and quality management systems for medical devices
                  • Strong, practical knowledge of R&D, NPI, supply chain, and quality control
                  • Strong experience with process value stream mapping, and change control management
                  • Experience with and solid understanding of statistical process controls, lean manufacturing, six-sigma implementation
                  • Demonstrated ability to manage multiple projects with a high degree of accuracy and timeliness
                  • Experience with combination medical device/pharmaceutical products

                  Skills and Attributes

                  • Strong analytical skills and critical thinking
                  • Excellent ability to troubleshoot and problem-solve, and to lead root cause analysis of quality issues in a manufacturing environment
                  • 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 “199 Chemical Process Engineer” in the subject line.


                  Senior Electrical Verification Engineer

                  Kardium has a unique opportunity for a Senior Electrical Verification Engineer. As a member of the Engineering Testing team, the Senior Electrical Verification Engineer will be a key member of the team responsible for specifying, performing, and overseeing verification and validation activities for Kardium’s medical device projects. Verification and validation necessitates interactions with all parts of the company including design engineering, clinical research, field operations, regulatory affairs, and manufacturing. This role is an excellent opportunity for someone looking to gain a broad and comprehensive understanding of medical device R&D on a leading-edge and complex product, provide technical leadership, and perform detailed technical work.

                  Responsibilities

                  Technical leadership of electrical and systems verification and validation team:

                  • Lead development and validation of electrical test methods and software analysis tools to be used in system characterization, verification, and validation
                  • Assist in creating the verification and validation strategy for the electrical and system components
                  • Provide guidance to design team to ensure that design input requirements are adequately written to support verification and validation activities
                  • Specify, design, and commission necessary electrical test fixtures and jigs for test automation
                  • Implement changes to verification and validation test methods and procedures to maintain compliance with updated medical device standards and regulations

                  Experience and Qualifications

                  • At least five years of experience with electrical and electronics hardware design and verification
                  • Bachelor’s degree or higher in electrical engineering or engineering physics
                  • Medical device regulatory experience, including application of standards such as IEC 60601
                  • Digital and analog signal processing and signal conditioning
                  • Statistics as applied to verification and validation testing
                  • Experimental design and measurement systems analysis

                  Skills and Attributes

                  • Strong electrical aptitude
                  • Strong written communication, verbal communication, and technical documentation skills
                  • Strong analytical skills and critical thinking
                  • Scripting experience is an asset
                  • Sound ability to manage multiple tasks with a high degree of accuracy and timeliness
                  • Flexible and adaptable to take on additional responsibilities as appropriate
                  • Proven ability to operate independently with minimal direction
                  • Detail-oriented
                  • Excellent interpersonal skills

                  How to Apply

                  To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “201 Senior Electrical Verification Engineer” in the subject line.