Mechanical Risk Engineer (Hybrid)

at  Kardium Inc

Your opportunity
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.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of

• 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 and Systems teams 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:

• 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.

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 - $110,000 (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.
Life at Kardium
What makes us a great place to work?
1. Our Purpose
2. Our People
3. Our Culture
At Kardium, we embrace diversity of background, experience, and perspective and we’re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.
We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Brazilian ERG and Irish ERG.
As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.
And our employees think we are great too – check out Glassdoor to learn more