421 System Risk Engineer
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.
As an integral part of the Quality Engineering team, you will have the opportunity to work across the biomedical research, mechanical, electrical, software, usability, and risk management domains. Your daily activities will centre around supporting and influencing product design and process development through system-level risk management activities. Critical to the success of this function are strong analytical skills and your high attention to detail and rigor in design analysis and ensuring all regulatory standards are met.
What you’ll be doing
Your responsibilities will include:
- Performing SW design safety risk analysis by identifying risks, devising and risk control strategies, and confirming the identified risks are adequately addressed.
- Authoring and maintaining the device risk file including dFMEAs, pFMEAs and hazard analyses.
- Participating in design reviews to ensure that risk management is an integral part of the product and process design.
- Providing assistance and guidance to the Engineering and Testing teams in the design of SW test plans and protocols based on the associated risk analyses.
- Performing impact analysis of design changes on the safety risk profile of the device.
- Assessing SW clinical field incidents and adverse events for impact on the safety profile of the device.
- Identifying cyber-security threats to the device and supporting compliance with security standards and frameworks (e.g., GDPR).
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 are suited to our approach and possess these attributes:
- Bachelor of science or engineering degree, with emphasis on software or electrical systems
- A minimum of 3 years’ experience in a regulated industry, preferably in biotechnology
- Working knowledge of risk management process (e.g., ISO 14971, ISO 60601, ISO 62304) and hands-on experience with risk management tools (Failure Mode and Effect Analysis, Hazard Analysis, etc.)
- Knowledge of information security standards and methodologies; in particular, GDPR
- Excellent written and verbal communication and technical documentation skills
- Strong analytical and interpersonal skills
- Excellent engineering aptitude and ability to come up to speed quickly on complex subject matter across multiple disciplines
- Flexible and adaptable to meet the needs of varying production schedules, and to take on additional responsibilities as appropriate
Why work at Kardium
A meaningful career working with a truly innovative technology and an ambitious team, combined with:
- Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
- A great working environment with opportunities to develop your skills and knowledge
- 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
- An engaged leadership team who believes in mentoring and growing employees’ careers
- Supportive and fun colleagues with plenty of social events to encourage people connections
- And our employees think we are great too – check out Glassdoor to learn more!
How to apply
To apply for this position, please send a cover letter and resume to email@example.com, using “421 System Risk Engineer” as the subject line. Indicate in your cover letter why you are interested in Kardium and in this specific position.
Thanks in advance for your interest in Kardium!
Kardium is a technology pioneer developing devices to address cardiovascular diseases. The company was founded in 2007 by a team with a track record of excellence in medicine, business, and engineering. Focused on building a world-class, internationally dominant medical device company, we believe in having lots of fun while working hard. We hire top individuals who are strong team players and trust them to make the right decisions to achieve our goals. Kardium has repeatedly been selected as one of the “Best Companies to Work for in BC” by BC Business Magazine and has ranked as the #1 Life Sciences and Health Services Company. In 2015, and again in 2021, Kardium was also awarded “Medical Technology Company of the Year” by Life Sciences BC. Visit our website at kardium.com.
To apply for this job email your details to firstname.lastname@example.org.