New Product Introduction (NPI) Process Engineer

Katalyst Healthcares and Life Sciences

Valencia, CA

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.
pply 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.

Requirements:

3-5 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).

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Vacancy posted 4 days ago

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