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- Apply Design Control principles to document requirements, specifications, test protocols, and test reports to comply with regulatory guidance and standards
- Develop concepts and prototypes for new and existing products and manufacturing processes
- Validate and verify device and parts designs and manufacturing processes through methodical scientific tests
- Document manufacturing and testing processes for Operations to ensure consistent process output
- Collaborate with cross functional teams including Regulatory Affairs, Clinical Affairs and Operations
- Bachelor's degree in Mechanical Engineering, Electrical Engineering or relevant field
- 5 plus years of medical device development and manufacturing experience
- Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up processes
- Proficient with CAD software and other design tools
- Stent, catheter or peripheral vascular intervention experience preferred
- $130,000 to 160,000 (Dependent on Experience)
Sr R&D Engineer - San Jose, United States - R&D Partners
Description
Our medical device client is recruiting for a Sr R&D Engineer to join their growing team.
Summary:
Qualifications:
Pay Scale:
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.