Your opportunity

You will be an integral part of the Quality Engineering team but collaborating intensively with the Mechanical, Manufacturing, and Testing teams. Your daily activities will center around supporting and influencing product mechanical design and manufacturing through risk management activities. Critical to the success of this function are strong analytical skills and your high attention to detail and rigor in analyzing risks and ensuring all regulatory standards are met.

Meaningful work you will be a part of

Your responsibilities will be to:

• Perform technical failure analysis of mechanical design of the Kardium Globe® product and provide guidance to the Mechanical team in design and development of risk control strategies.
• Work closely with the Mechanical team to identify critical elements of designs.
• Provide support to the Mechanical and Manufacturing teams in failure analysis, root cause investigations, documentation review and approval, and NPI activities.
• Perform impact analysis of design and manufacturing changes on the safety risk profile of the device.
• Provide guidance to the Mechanical and Testing teams in the design of test plans and protocols based on the associated risk analyses.
• Perform risk analysis and determine quality disposition for variance requests and non-conformances

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 will be successful in this role because you possess these attributes:

• Minimum bachelor's degree in Mechanical Engineering, Biomedical Engineering, System Engineering, Mathematics, or Physics.
• A minimum of 4 years' experience in a regulated industry, preferably in medical devices or 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 & verbal communication and technical documentation skills.
• Strong analytical and interpersonal skills.
• Excellent mechanical/technical aptitude and 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.

Compensation

Kardium has listed the total cash compensation range (base salary + 5% RRSP contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.

As a permanent employee, you will also participate in Kardium's stock option plan.

• $80,000 - $114,000 (CAD Annually)

Your Benefits & Well-being

Total cash - the total cash we've listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.

Comprehensive medical & dental coverage - for all permanent employees - effective as of Day 1, with no waiting period.

Work-day flexibility - additionally, we provide 3 personal days per year.

Support - for you (and your dependents) overall well-being.

Career progression and learning support.

Professional membership support.

Family building - we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment