Role SummaryThe
Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.
Key Responsibilities- Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
- Design and develop inprocess and receiving inspection systems for new components and processes.
- Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
- Manage process development projects from concept through implementation; collaborate with cross-functional teams.
- Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
- Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).
Experience Requirements- 5-7+ years in manufacturing engineering or quality engineering within an FDAregulated environment (medical devices, pharma, diagnostics, biotech).
- Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.
- Electrical and mechanical engineering background applied to automated manufacturing systems.
- Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.
- Proficiency in DOE, FMEA, CAPA, and rootcause investigation.
- Experience supporting new product introductions and process scaleup.
