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Process Engineer
2 months ago
Medical Device Process Engineer
9 month+ possible temp to direct
Work on-site in Santa Clara
Prefer packaging validation experience with ISO 11607 or peel testing (ASTM F88) and/or bubble testing (ASTM F2096) would be beneficial too. Salt Pot or etching process experience would also be a plus.
- Develop and execute process validation protocols (IQ, OQ, PQ) in accordance with FDA and ISO regulations
- Familiar with medical device manufacturing processes; UV curing, catheter shaft fabrication (braiding and plastic re-flow), fusing, tipping, soldering, shaping, plastic injection molding, 3-D printing, sterilization processes, CER environment monitoring, and sterile packaging sealing
- Develop and improve manufacturing processes, tools, and equipment to enhance efficiency. Design, develop, and document assembly fixtures to improve yields and reduce costs.
- Train manufacturing personnel on updated processes and procedures.
- Participate in risk management activities, including authoring and maintaining PFMEA’s to identify and mitigate potential risks in manufacturing processes.
- Experience with statistical analysis and tools such as Minitab.
- Proficient in Solidworks
- Generate and maintain accurate and comprehensive documentation, including Standard Operating Procedures (SOPs), manufacturing work instructions, Lot History Records, and DMR’s.
- Investigate and resolve manufacturing-related quality issues through root cause analysis and corrective/preventive actions
Benefits (employee contribution):
- Health insurance
- Health savings account
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Life insurance
- Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
