262 Systems Biomedical 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.

What you’ll be doing…

As our Systems Biomedical Engineer, you will be an integral part of our multidisciplinary engineering team and will have the opportunity to work across the biomedical research, mechanical, electrical, software, usability, and risk management domains. Your daily activities will centre around supporting product design and process development through system requirement generation and analysis. Your tasks will also include usability work such as design, documentation, execution, and analysis of usability testing to inform design and validate the user interface (GUI and physical) is safe and effective.

Your responsibilities will include:

  • Authoring and maintaining multidisciplinary system requirements and specifications.
  • Leading and participating in system-level design reviews to ensure that requirement management is an integral part of the reviews.
  • Planning, documenting, executing, and analysing formative (informal) and summative (formal) usability studies.
  • Developing and maintaining usability documentation.
  • Assisting in establishing and reviewing traces between requirements 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 requirement analyses.
  • Root cause analysis of factors leading to use errors or close calls.
  • Brainstorming of training, documentation, or design changes to reduce or eliminate use errors.
  • Provide logistical support for external testing activities.
  • Perform other duties as assigned.

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.
  • A minimum of 3 years’ experience in a regulated industry, preferably in medical devices or biotechnology.
  • Knowledge of mechanical or electrical/software systems is an asset.
  • Human Factors or UX experience is a plus.
  • ISO 13485, IEC 62366, and change management experience would be an asset.
  • Excellent written and verbal communication and technical documentation skills.
  • Strong analytical and interpersonal skills.
  • Ability to identify, acquire, and utilize resources and information needed to resolve issues outside the candidate’s core knowledge base.
  • Ability to work as part of a team as well as independently.
  • Flexible and adaptable to meet the needs of varying production schedules, and to take on additional responsibilities as appropriate.
  • Hands-on experience assembling, configuring, and troubleshooting mechanical, electrical, and software systems is a plus.
  • High degree of drive and motivation.

Why work at Kardium?

We know you are looking for a meaningful career. We can offer you that, and more:

  • Knowing every day that 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 by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and 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…

To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “262 Systems Biomedical Engineer” in the subject line.

To apply for this job email your details to jobs@kardium.com