Sr. Design Quality Engineer
5900 First Ave S Seattle, WA 98108
Position Title: Sr. Design Quality Engineer
Position Description: Protingent Staffing has an exciting direct hire opportunity with our client in Seattle, Washington.
- Provide quality engineering and reliability input to all new projects, including the establishment of quality and reliability design constraints and design evaluation criteria.
- Plan, coordinate, execute and lead design verification testing against product requirement specifications
- Oversee the Risk Management program, including creating Risk Management Plans, coordinating risk analyses, participating in FMEA’ s, and maintaining Risk Management Reports and Files.
- Participate in design reviews to ensure customer and regulatory requirements have been properly translated in to design inputs which are complete, unambiguous and do not conflict.
- Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes.
- Develop an understanding of the current product to assist with product updates and maintenance releases.
- Assist in the preparation of design documentation to ensure the Design History File is maintained.
- Assist with creating Essential Requirements Checklists and Technical Files for EU submissions.
- Create, implement and teach new quality systems as required.
- BS degree in Engineering discipline or equivalent degree + experience
- Minimum of eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.
- Direct experience with FDA QSR and ISO 13485 compliance.
- Knowledge of development, validation and manufacture of medical devices.
- Direct experience with electro-mechanical equipment required, including IEC
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
Sr. Technical Recruiter
I have been a Technical recruiter for over 20 years, much of that time with Protingent. My passion is teaching people how to manage their career and effectively look for work. I will keep working with a candidate until we find that right fit. I want to know what your dream job would be so I can help you find it.