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Outset Medical is seeking a Manufacturing Engineer - NPI Lead to oversee New Product Introduction activities for medical devices in Tijuana, Mexico. The role requires extensive experience in medical device manufacturing, specifically with disposable products, and involves leading cross-functional teams to ensure product readiness and compliance.
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Job Summary
The NPI lead coordinates New Product Introduction (NPI) activities from development through manufacturing transfer and production ramp for both capital equipment and disposable medical devices.
This role provides technical and people leadership to NPI and/or Manufacturing Engineers and serves as the manufacturing owner for NPI programs, ensuring products are manufacturable, scalable, compliant, and delivered on time, cost, and quality targets.
Partner closely with R&D, Quality, Supply Chain, Operations, PMO, Regulatory, and external suppliers/CMs to drive successful product launches in a regulated medical device environment.
Matching Summary
Match Score: 75
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Outset Medical is seeking a Manufacturing Engineer - NPI Lead to oversee New Product Introduction activities for medical devices in Tijuana, Mexico. The role requires extensive experience in medical device manufacturing, specifically with disposable products, and involves leading cross-functional teams to ensure product readiness and compliance.
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Skills & Requirements
Must-have
New Product Introduction (NPI) leadership
Medical device manufacturing
DFM/DFA and cost optimization
Process and equipment validation
High-volume manufacturing experience
Nice-to-have
Lean Six Sigma Green Belt
Extrusion and injection molding
Electro-mechanical assemblies
Key Requirements
7+ years of medical device NPI experience
Previous supervisory or team-lead experience
Strong knowledge of FDA QSR, GMP, and ISO 13485
Proficiency with Microsoft Office, Minitab, and CAD tools