<h1 class="job-title">Mechanical Risk Engineer (Hybrid)</h1>\n <h3 class="job-location"><a target="_blank" href="https://maps.google.com/maps?q=Burnaby%2C%20British%20Columbia%2C%20Canada&zoom=14&size=512x512&maptype=roadmap&sensor=false">Burnaby, British Columbia, Canada</a></h3>\n <div class="job-content">\n
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 minimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other heart-related complications.
Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.\n
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.\n
As the Mechanical Risk Engineer your responsibilities include:\n
• 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\n
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.\n
You are suited to our approach and possess these attributes:\n
• Bachelor’s degree in mechanical or system engineering, math, or physics
• A minimum of 3 years’ experience in a regulated industry, preferably in 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
Why work at Kardium\n
A meaningful career working with a truly innovative technology and an ambitious team, combined with:\n
- Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide \n
- A great working environment with opportunities to develop your skills and knowledge \n
- 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 \n
- An engaged leadership team who believes in mentoring and growing employees’ careers \n
- Supportive and fun colleagues with plenty of social events to encourage people connections \n
- And our employees think we are great too – check out Glassdoor to learn more! \n
Thanks in advance for your interest in Kardium!\n