Description
My client, a leading Medical Device company located in Northern Illinois, now has a fantastic 9 month contract opportunity for a Senior Risk Engineer.The company is a worldwide leader in Consumable Medical Devices and is seeking a Senior Risk Engineer to work in the risk management for on-market change requests and new product development. This is an excellent opportunity to work at the cutting edge of the Medical Device field and to get fully immersed in global projects.
The Senior Risk Engineer will be responsible for all aspects of risk management including risk engineering project planning, creating and maintaining product risk files, identifying and tracing risk controls from the hazard analysis to the product requirements. The successful candidate will also work collaboratively with a cross-functional team with an emphasis on delivering a product risk file that will drive the required risk controls for the design outputs as well as be the reference for the design verification sample size justification.
Candidates for this position must have the following skills and experience:
- Minimum BS Degree in Mechanical, Biomedical or Materials Engineering.
- 6 years industry experience within Systems Engineering for Medical Devices with a BS and 3+ years experience with a MS or PhD.
- Experience with drug delivery therapies and infusion technology.
- Experience with associated consumables of infusion technology.
- Experience with medical product submissions to fDA/5012K; hazard & reliability analysis.
- DOORs experience.
Apply online now for immediate consideration or contact Tom Bakker on for further information.
To find out more about Real please visit www.realstaffing.com