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Overview
Process Development Engineer — Santa Clara, CA • Duration: Long-term Contract with possible Full-Time Conversion
Responsibilities
- Provide technical and operational support for consumable and cartridge manufacturing, bridging new product implementation with process optimization to ensure compliance, quality, and manufacturing robustness.
- Perform process troubleshooting, validation (IQ/OQ/PQ), process characterization, in-process controls (CTQs/IPCs), root cause investigations, and statistical analysis (DOE/SPC); drive continuous improvement initiatives using Lean Six Sigma.
- Collaborate in a GMP/ISO 13485 regulated environment; author technical documentation (ERP/SAP); participate in audits, CAPAs, and technology transfer from R&D to operations.
Qualifications
- Bachelor’s or higher in Biomedical, Chemical, Mechanical Engineering, or related discipline.
- Minimum 5 years’ experience in medical device, IVD, or regulated manufacturing.
- Hands-on experience with process validation, technology transfer, and manufacturing support.
- Proficiency in DOE, SPC, and statistical tools (JMP, Minitab).
- Familiarity with GMP, ISO 13485, FDA QSR (21 CFR 820) compliance.
- Experience with microfluidics, surface chemistry, reagent formulation, cleanroom operations, or automated liquid handling.
- Lean Six Sigma Green Belt certification.
How to Apply
Please respond with your updated resume and contact information to /
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