Process Engineer – Product Development
5 days ago
Position Summary
The Process Engineer (Product Development) supports the design, development, validation, and transfer of manufacturing processes for medical devices. This role ensures robust, compliant processes aligned with ISO 13485, FDA 21 CFR 820, and customer requirements, supporting successful product commercialization.
Key Responsibilities
- Develop and optimize manufacturing processes (molding, assembly, bonding, packaging).
- Support new product development through prototyping, DOE, and scale-up activities.
- Participate in DFM/DFA with Design Engineering and clients.
- Define process requirements, specifications, and acceptance criteria.
- Author, execute, and report IQ/OQ/PQ process validations.
- Support tooling qualification activities (T0/T1, FAT/SAT).
- Analyze process capability, yield, and scrap (Cp/Cpk, SPC).
- Support root-cause investigations during pilot and early production builds.
- Develop PFMEA, Control Plans, and process documentation.
- Collaborate cross-functionally with Engineering, QA, Operations, suppliers, and automation partners.
- Contribute to continuous improvement initiatives.
Qualifications
- Bachelor's degree in Mechanical, Industrial, or related Engineering discipline.
- 1–5 years of process engineering experience (medical device preferred).
- Experience with process development, validation (IQ/OQ/PQ), and statistical tools (DOE, SPC).
- Working knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971 principles.
- Strong technical documentation and communication skills.
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