New Product Introduction (NPI) Process Engineer

Valencia, CA, US • Posted 60+ days ago • Updated 3 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Management
Training
Production Planning
Regulatory Compliance
Process Modeling
Research and Development
DV
Testing
Reporting
Product Launch
Inspection
Automated Testing
Collaboration
Manufacturing Engineering
Process Engineering
Medical Devices
Manufacturing
Bill Of Materials
UPS
New Product Introduction
NPI
IQ
OQ
PQ
Design For Manufacturability
SolidWorks

Summary

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).

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 7a037e8e53b2e65337686741c059892b
Posted 30+ days ago

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New Product Introduction (NPI) Process Engineer

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Job Details

Skills

Summary

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