334 System Risk Engineer
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.
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 center 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…
- Identifying design safety risks and risk control strategies.
- Evaluating design and risk profile of device in accordance with ISO 60601 in collaboration with the design and testing teams.
- Authoring and maintaining the device risk file including dMFEAs, pFMEAs, and hazard analyses.
- Participating in design reviews to ensure that risk management is an integral part of the reviews.
- Providing assistance and guidance to the engineering and testing teams in the design of test plans and protocols based on the associated risk analyses.
- Assisting the engineering and manufacturing teams with root-cause investigations and corrective and preventive actions.
- Performing impact analysis of design changes on the safety risk profile of the device.
- Participating in the review and disposition of non-conforming products and material, as a member of the Material Review Board.
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:
- Bachelor of science or engineering degree, with emphasis on 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) and hands-on experience with risk management tools (Failure Mode and Effect Analysis, Hazard Analysis, etc.)
- 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?
We know you are looking for a meaningful career. We can offer you that, and more:
- Every day you know you are making a difference by helping treat a condition that debilitates millions of people worldwide.
- A great flexible working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology.
- An engaged leadership team who believes in mentoring and growing employees’ careers.
- Supportive colleagues and plenty of fun social events to encourage employee interactions.
- And our employees think we are great too – check out Glassdoor to learn more!
How to apply…
If this position appeals to, you apply today by sending your résumé and cover letter to email@example.com, with the job title “334 System Risk Engineer” in the subject line.
To apply for this job email your details to firstname.lastname@example.org.