What are the responsibilities and job description for the New Product Introduction (NPI) Process Engineer position at Katalyst CRO?
Responsibilities
- Manage prototype and pilot builds for new product introduction, including operator training and coordination with production planning.
- Collaborate cross-functionally with Manufacturing and Quality teams to ensure process adoption and compliance.
- Apply Design for Manufacturability (DFM) principles to tooling, process design, and product integration.
- Support the R&D team with Design Verification (DV) testing and technical reporting.
- Plan and execute Process Validations (IQ/OQ/PQ) for product launch.
- Conduct Packaging Validations for new products.
- Develop and implement procedures for Receiving Inspection, First Article Inspection, and Automated Test Equipment (ATE) setup.
- Troubleshoot and sustain ATE processes.
- Contribute to Process Failure Mode and Effects Analyses (pFMEAs) in collaboration with Manufacturing Engineering.
- 35 years of experience in manufacturing process development and sustaining engineering.
- Background in medical device manufacturing, including implantable and Class II/III devices.
- Interpret engineering drawings, BOMs, and tolerance stack-ups.
- New Product Introduction (NPI), design verification, and process validation.
- Experience developing and executing IQ/OQ/PQ protocols.
- Knowledgeable in product lifecycle transitions and DFM principles.
- Proficiency in SolidWorks CAD (preferred).
