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Risk Manager
2 weeks ago
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.
As part of the Quality Engineering team, and in close cooperation with the Engineering and Manufacturing teams, the Risk Manager will coordinate the development and improvement of Kardium’s medical device Risk Management systems and processes, coordinate the execution of risk management activities, and assure the timely, accurate and independent evaluation of product risk profile throughout the product life-cycle, from concept to end-of-life.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of
**Your responsibilities will include**:
- Author, review and improve as needed risk management system procedures, and maintain and improve risk management tools and techniques
- Author, review and maintain risk management documents - e.g., Risk Management Plan (RMP), Risk Management Report (RMR), Risk Management File, etc.
- Scope, prioritize, track and conduct risk management activities - e.g., dFMEA, pFMEA, uFMEA, and drive the development of thorough, accurate and practical risk estimations, risk controls and risk/benefit analyses
- Participate in design reviews to ensure that risk management is an integral part of the reviews
- Coordinate the conduct of risk reviews of design verification and validation documentation
- Coordinate the independent evaluation of risk management documentation to ensure completeness, adequacy and proper implementation of all necessary risk controls
- Assist with the analysis of ECOs, product & production quality, and post-market surveillance data to evaluate impact on product risk profile, and recommend any necessary risk control activities
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:
- Education: Bachelor of Science degree (Mechanical, Applied Physics, etc.) or equivalent engineering degree
- At least 5 years of QA or Quality Engineering experience in a multi-disciplinary, manufacturing environment in a regulated industry, preferably in the area of high-risk medical devices
- Working knowledge of risk management process (ISO14971) and hands-on experience in risk management tools (FTA, FMEA, etc.)
- Knowledge of probability and statistics related to risk management
- Experience working in environments compliant with ISO 13485 and U.S. FDA Quality System Regulation
- Multidisciplinary understanding of the company’s products
- Excellent written & verbal communication and technical documentation skills.
- Strong interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization.
- Strong organizational, leadership and management skills
- Flexible and adaptable to take on additional responsibilities as appropriate.
Compensation
As a permanent employee, you will also participate in Kardium’s stock option plan.
- $105,000 - $131,000 (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
We collaborate
