Mechanical Risk Engineer (Hybrid)

Kardium Inc. • Burnaby, BC

6d • CA$80,000 - CA$114,000 • Hybrid

About The Position

By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.
Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
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.

Requirements

• 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.

Nice To Haves

• Flexible and adaptable to meet the needs of varying production schedules, and to take on additional responsibilities as appropriate.

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level