Medical Device Software Quality Engineer
San Diego, CA
Medical Device Software Design Quality Engineer
Our client is a global leader in diagnostic and reagent healthcare products. They research, develop and manufacture a number of medical devices and IVD’ s. They are in need of a Software Design Quality Engineer with to help with a DHF remediation of their embedded software.
Principle Duties and Responsibilities:
The client is currently going through a DHF remediation. Looking for a Software Design QE to help execute on their remediation plan. This person will Assume a Subject Matter Expert [SME] on new product development teams in the areas of: DHF, risk management, change control, requirements management for all classifications of product – IVD, Medical Device.
Should have extensive experience with Risk Management and DHF’ s. Should also have strong understanding of medical device product design and regulatory processes.
- Medical Device/IVD: 8-10 yrs
- Software Quality Engineer – 5-7+ years
- Design History File Remediation (DHF)
- Embedded Software
Job Type: Contract