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.
Quality ExpectationsDemonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.
Ensures proper documentation discipline and supports Quality System compliance.
Special requirement:
- 3.00 GPA minimum
- RUM or Polytechnic University graduates
- BS in Engineering
