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.

Quality Engineer

Software Engineer

QA Specialist

Compliance Specialist

Systems Engineer

Clinical Specialist

Mechanical Designer

Purchasing Agent

Manufacturing Process Engineer

Mechanical Designer – Manufacturing


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.


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.


QA Specialist

Kardium has a unique opportunity for an experienced Quality Assurance (QA) Specialist to join our world-class team in the development of Kardium’s novel Globe® systems for percutaneous treatment of atrial fibrillation.

As a member of the Quality Assurance team, and in close cooperation with the Engineering, Supply Chain, and Manufacturing teams, the QA Specialist will be responsible for product release and QMS implementation efforts to support successful product launches and ongoing production. The position offers an opportunity to implement aspects of quality assurance, and a chance to be involved in the design change process of cutting-edge medical devices.

The incumbent provides direct manufacturing quality assurance support to production activities in a ISO-13485 regulated environment. He/she acts as a key quality contact for manufacturing for discrepancy management, device history record review, and production line support; assures compliance and solves routine quality issues in accordance with ISO regulations, Kardium standards, and applicable Regulatory Guidelines. The successful candidate will apply their ISO 13485, US FDA QSR experience, and their quality operation knowledge to assist with QMS-related improvements.

Responsibilities

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

QMS 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

Education & Experience

  • Bachelor of Science degree in a technical discipline (e.g. Engineering, Physics, etc.)
  • At least 3 years’ QA experience in a manufacturing environment in the biotech industry; 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

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

Application Process

To apply for this position, please send a cover letter and résumé to jobs@kardium.com using “098 QA Specialist” as the subject line.


Compliance Specialist

Kardium has a unique opportunity for a Compliance Specialist. As a member of the QA Team, the Compliance Specialist will provide support to the maintenance of Kardium’s Quality Management System (QMS). The position will report to the Compliance Manager.

Responsibilities

  • Leads QMS expansion and improvement projects, and any other tasks required to maintain QMS and product compliance, including assistance with the development  and delivery of QMS training
  • Assists with development and assessment of QMS performance metrics
  • Assists with external audits and regulatory inspections
  • Acts as a member of the internal audit team performing audits of the QMS system, including assisting with planning, preparing reports, and other audit documentation, and performing follow-up activities
  • Performs supplier qualification and monitoring activities, including site audits
  • Provides regulatory support, including assisting with regulatory submissions, reporting to Competent Authorities, and maintenance of the company’s regulatory list of external standards
  • Provides QA support of Equipment Management System
  • Performs any other QA tasks as required

Education & Experience

  • Bachelor degree, preferably in a technical/science field, or equivalent combination of education and experience
  • Three to five years’ QA experience in a manufacturing environment
  • Strong working knowledge of ISO 13485 and FDA QSR or ISO9001 in a regulated industry
  • Experience with electronic document and electronic record management systems
  • Previous experience in auditing techniques desirable

Skills

  • Strong analytical skills and critical thinking
  • Effective written and verbal communication and technical documentation skills
  • Strong computer skills (MS Office, Access, Excel)
  • Organized and detail-oriented
  • Excellent interpersonal skills
  • Willingness to travel occasionally
  • 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 “099 Compliance Specialist” in the subject line.


Systems Engineer

Kardium has an exciting opportunity for a motivated Systems Engineer to join our world-class team in the development of a novel catheter for percutaneous treatment of atrial fibrillation. As a member of the Systems Engineering team, you will be a key member of Kardium’s device development team, working closely with the software, electrical, and biomedical research teams to characterize and improve our product’s performance.

Responsibilities

  • Create and maintain system analysis tools
  • Analyze the behavior of the system to assess robustness and stability of the system
  • Investigate issues identified during verification and during clinical of the device
  • Maintain the system level specifications for the electrical and software systems of the product
  • Become familiar with and stay current on relevant medical device standards and regulations
  • Work closely with the electrical, software, and research teams to improve analysis methods and inform future design

Education & Experience

  • Bachelor’s degree in engineering or computer science
  • Experience with electrical and software systems design
  • Experience with signal processing and data analysis
  • Experience writing specifications and design notes
  • Experience with Java and MATLAB is preferred
  • Practical knowledge of medical device regulatory requirements and standards, such as IEC 60601 and IEC 62304, is preferred

Skills

  • Strong analytical and critical thinking skills
  • Effective written and verbal communication and technical documentation skills
  • 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
  • Excellent interpersonal skills

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com with the job title “100 Systems Engineer” in the subject line.


Clinical Specialist

Kardium is preparing for the European launch of our new, innovative Globe® mapping and ablation system, which will be used to treat atrial fibrillation.

We have an exciting opportunity for a Clinical Specialist in the area of electrophysiology. The Clinical Specialist will be responsible for attending cardiac ablation procedures in Germany and Switzerland to provide technical and logistical support for our Globe system.

This position will be based in Europe.

Responsibilities

  • Assist clinical staff using the Globe system during cardiac ablation procedures
  • Train electrophysiologists and other clinical staff on the use of the Globe system
  • Provide technical support to hospital staff on the Globe system
  • Provide customer and technical feedback regarding device use to Kardium

Education & Experience

  • University degree, or equivalent
  • Experience working in a clinical environment
  • Experience with interventional cardiac catheters an asset

Requirements & Skills

  • Strong mechanical and technical aptitude
  • Familiarity working with complex software
  • Ability to work in Germany and Switzerland
  • Fluency in German
  • Ability to operate independently with minimal direction
  • Flexibility 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 “101 Clinical Specialist” in the subject line.


Mechanical Designer

Kardium is looking for a talented and driven Mechanical Designer to join the medical development team. The successful candidate 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 candidate include strong hands-on and analytical skills as well as the ability to transform concepts to final design.

Responsibilities

  • 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
  • Travelling occasionally 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 “102 Mechanical Designer” in the subject line.


Purchasing Agent

The Purchasing Agent is accountable for ensuring procurement of goods and services meets all delivery commitments along with contractual and regulatory obligations. The role will include involvement in material planning strategies and cost control activities through all product life cycle stages. The successful candidate is expected to actively contribute to the identification and implementation of opportunities to improve all Supply Chain business metrics. The position offers exposure to a wide variety of technologies and quality system controls and a chance to be involved in the commercialization of cutting-edge medical devices.

Responsibilities

  • Release of purchase orders to approved suppliers per material planning requirements
  • Proactively review upcoming deliveries and initiate escalation strategies as necessary to mitigate potential delivery risks
  • Continuously engage with suppliers to understand capacity constraints and other supply risks and communicate supply issues to internal stakeholders
  • Expedite deliveries of material purchases as required
  • Facilitate return of non-conforming product and ensure appropriate credits are received
  • Assist Supplier Quality Engineering with non-conformance investigations and corrective actions
  • Ensure necessary Deviation Permits are approved and documentation requirements communicated
  • Provide purchasing support for engineering and other non-production activities by soliciting quotations and other product information
  • Proactively identify opportunities to improve quality, on-time delivery and inventory turns as well as reduce cost and risk.

Experience & Qualifications

  • Minimum 1 year of Purchasing or other Supply Chain experience
  • Basic experience with and exposure to cost reduction strategies
  • Familiarity with inventory management concepts and best practices
  • Strong mathematical and analytic skills
  • Knowledge and working experience of ERP/MRP systems
  • Experience working in highly regulated environments, such as ISO 13485 or AS9100, is desirable
  • Formal training or procurement accreditation considered an asset

Personal Attributes

  • Strong interpersonal skills and ability to communicate effectively at all organizational levels
  • Organizational skills and ability to prioritize and manage multiple, competing deliverables
  • Critical thinker with the ability to provide accurate and timely information and recommendations
  • Flexible and adaptable to take on additional responsibilities as appropriate
  • Self-motivated with a strong desire to contribute positively in a demanding yet motivating and energetic working environment

Application Process

To apply for this position, please send a résumé and cover letter to jobs@kardium.com with the job title “103 Purchasing Agent” in the subject line.


Manufacturing Process Engineer

Kardium has a unique opportunity for an experienced senior Manufacturing Process Engineer. As a member of the Manufacturing team, the Manufacturing Process Engineer will be responsible for the production floor layout for a complex medical device, organization of the material flow and manufacturing equipment, working with the process engineering team in prioritizing and implementing process improvements, and providing DFM inputs into product enhancements and future products. This position will report to the Manufacturing Team Lead.

Responsibilities

The Manufacturing Process Engineer will be responsible for:

Manufacturing process development:

  • Based on daily interaction with the Production Manager, Supervisor, and Production Technicians, provide regular feedback to engineering teams on process bottlenecks and areas for potential improvement
  • Work with process owners in engineering teams to resolve root causes for ongoing quality issues for various manufacturing processes, and drive implementation of solutions
  • Develop business case and drive process improvements to reduce overall touch time by Production Technicians for various steps in the manufacturing process
  • Look for key areas of process variability and develop manufacturing solutions to reduce this variability

Cleanroom organizational optimization:

  • Plan manufacturing workstation layout in cleanroom to maximize efficiency through lean manufacturing methodologies
  • Develop and drive implementation of WIP and finished good product storage solutions within manufacturing cleanroom environment
  • Drive process layout for ongoing cleanroom expansion to allocate production space for current and future product designs
  • Provide feedback on supporting utilities requirements to facilities engineering team to ensure that all workstations have the required infrastructure
  • Develop detailed cycle time and process flow model for current manufacturing process, and develop strategies for debottlenecking to maximize line capacity
  • Perform process capability studies on critical manufacturing processes

New Product and Process Development:

  • Liaise with the Engineering and QA/QC teams to roll out product design and process changes in an organized and controlled manner into production
  • Ensure new production processes that are rolled out are compliant with Kardium’s medical device quality management system (QMS)
  • Provide input into product design to ensure design is optimized for manufacturability
  • Work with Engineering teams to develop suitable processes for next-generation products

Education and Experience

  • Bachelor’s degree in mechanical 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
  • Experience in developing manufacturing floorplan layouts based on activity relationship analysis is desirable

Preferred Requirements and Skills

  • Strong analytical skills and critical thinking
  • 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 “104 Manufacturing Process Engineer” in the subject line.


Mechanical Designer – Manufacturing

Kardium has a unique opportunity for an experienced Mechanical Designer. This position will be responsible for designing and implementing improvements to the manufacturing facilities and to the jigs and fixtures used in the production of a novel medical device. This position will report to the Manufacturing Team Lead.

Responsibilities

The Mechanical Designer will conduct the following activities as required:

  • Design, prototype, test, fabricate, and integrate jigs, fixtures, and tools into production plant to reduce wasted motion, time, and space
  • Develop methods to improve on raw and work-in-process material storage
  • Enhance the ergonomics of workstations, including tool storage
  • Design methods and tooling to assist with the maintenance of production equipment
  • Based on regular interaction with Production and Quality Control technicians, identify potential improvements to equipment, jigs, and fixtures that would increase quality and productivity
  • Ensure that deliverables built are compatible with an ISO 7 cleanroom environment, when required

Education and Experience

  • Strong background in machining, with CAD/CAM and CNC machining experience
  • Bachelor’s degree or a diploma in a technical field, or equivalent combination of education and experience
  • Minimum 2 years’ experience in a manufacturing environment, preferably in the biotechnology, pharmaceutical, diagnostics, or medical devices industry
  • Strong, practical knowledge of lean methodology
  • Practical knowledge of equipment maintenance procedures
  • Ability to manage multiple projects with a high degree of accuracy and timeliness

Preferred Requirements and Skills

  • Excellent interpersonal skills
  • Effective written and verbal communication as well as documentation skills
  • Ability to operate independently with minimal direction
  • Detail-oriented
  • Prior exposure to Good Manufacturing Practices and working in a Cleanroom environment
  • Flexibility to take on additional responsibilities as appropriate
  • Hands-on experience assembling, configuring, and troubleshooting mechanical and electrical systems
  • Strong analytical skills and critical thinking

How to Apply

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “105 Mechanical Designer – Manufacturing” in the subject line.


 

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