Your Opportunity
By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a groundbreaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure and other heart-related complications.
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.
What you’ll be doing…

• 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 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:

• 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 – 110,000 (CAD Annually)

Your Benefits & Well-being
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.
Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
Career progression and learning support.
Professional membership support.
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, 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