Fremont, CA 94538
- Medical equipment or device design experience a plus
- SolidWorks, EPDM, Agile
- Experience working in R&D, supporting NPI and transferring product to Mfg.
- Experience with machine shop tools (manual mills, lathes...etc.)
- Familiar with ISO 13485, risk analysis ISO 14971
- Experience working in a fast-paced, hands-on environment.
- Support new product development as well as NPI and transfer to Mfg. activities
- Support cost reduction design, development of alternative design for DFM and part obsolescence
- Work with external vendors and consultants to finalized design and prototypes
- Responsible for all CAD modeling, drawings, released documentation per ISO 13485