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 Control Technician

Quality Engineer

Software Engineer

Mechanical Test Engineer

Quality Assurance Specialist


Quality Control Technician

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

Responsibilities

The Quality Control Technician will be responsible for:

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

Education and Experience

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

Required Skills

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

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


Quality 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.


Mechanical Test Engineer

Kardium has a unique opportunity for a Mechanical Test Engineer. As a member of the Engineering Testing team, you 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, while also performing detailed technical work.

Responsibilities

Design test protocols and methods

  • Assist in creating the company’s verification and validation strategy and design tests necessary to perform product design verification and process validation testing
  • Provide guidance to design team to ensure that design specifications are adequately written to support verification activities
  • Develop and validate test methods
  • Design and fabricate test fixtures and jigs using CAD and CAM software
  • Become familiar with and stay current on relevant medical device standards and regulations

Execute and document tests

  • Write test protocols
  • Execute tests
  • Work with design teams in root cause analysis
  • Write test reports
  • Interface with third party test labs

Education and Experience

  • Bachelor’s degree or higher in engineering (mechanical, mechatronics, or engineering physics is preferred)
  • Minimum 3 years of experience with design verification and validation of mechanical components and systemsin the biotechnology, pharmaceutical, diagnostics or medical devices industry, or 5 years of experience with hands-on mechanical orelectro-mechanical testing in industry
  • Experience with and solid understanding of statistics as applied to verification and validation testing
  • Strong, practical knowledge of mechanical systems, experimental design, and measurement systems analysis
  • Excellent ability to troubleshoot and problem-solve
  • Strong experience with writing specifications, test protocols, and test reports
  • Experience in a laboratory environment, including proper experimental data collection and Good Documentation Practice
  • Practical knowledge of medical device regulatory requirements and standards such as IEC 60601, ISO 10555, ISO 10993, ISO 13485, ISO 14971, and ISO 17025

Skills

  • Strong analytical skills and critical thinking
  • 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 cover letter and résumé to jobs@kardium.com using “097 Mechanical Test Engineer” as the subject line.


Quality Assurance Specialist

Kardium has a unique opportunity for an experienced Quality Assurance (QA) Specialist. As a member of the QA team, the QA Specialist will provide direct QA support to the Manufacturing and Engineering teams, and to the daily operations of Kardium’s Quality Management System (QMS).

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 Quality Assurance Specialist” as the subject line.


 

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