203 Mechanical Risk Management 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 part of the Quality Engineering team, you will coordinate risk management activities related to mechanical subsystems of the company’s products in close cooperation with the Engineering and Manufacturing teams, and assure the timely and accurate evaluation of risk in engineering projects. Critical to the success of this function is strong analytical skills and your high attention to detail and rigour in analyzing risks and ensuring all regulatory standards are met.
What you’ll be doing…
As the Mechanical Risk Management Engineer your responsibilities include:
- Analyzing device risks for acceptability and documenting control measures.
- Authoring and maintaining design and process Failure Mode and Effects Analyses (dFMEA and pFMEAs) and associated documentation including process requirements.
- Participating in (mechanical system) design reviews to ensure that risk management is an integral part of the reviews. Assisting in establishing and reviewing traces between risk items and process and product specification items in order to maintain consistent forward and backward traceability.
- 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 Mechanical and Manufacturing teams with root cause investigations and corrective and preventive actions (CPAs).
- As a member of the Material Review Board, participating in the review and disposition of non-conforming products and material.
- Authoring the risk assessment of Change Control documentation and of Deviation Permits.
- Conducting the risk review of Work Instructions and material reworks.
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 (mechanical engineering is preferred)
- A minimum of 3 years’ experience in a regulated industry, preferably in biotechnology
- Strong analytical and interpersonal skills
- Excellent mechanical aptitude and ability to come up to speed quickly on complex subject matter
- 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 and verbal communication and technical documentation skills
- 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 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 firstname.lastname@example.org, with the job title “203 Mechanical Risk Management Engineer” in the subject line.
To apply for this job email your details to email@example.com