Seeking a Process Development Engineer to support the development, validation, and implementation of new manufacturing processes, including 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 in‑process 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 FDA‑regulated 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 root‑cause investigation.
- Experience supporting new product introductions and process scale‑up.
Quality Expectations:
- Demonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.
- Ensures proper documentation discipline and supports Quality System compliance.