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.

The NPI Lead partners 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.

Essential Job Functions and Responsibilities

Lead and supervise NPI and/or Manufacturing Engineers supporting new product programs.

Own manufacturing readiness for NPI programs from concept through production release and ramp-up.

Serve as the primary manufacturing interface to R&D;, driving DFM/DFA, cost optimization, and risk reduction throughout development.

Develop and scale manufacturing processes, tooling, fixtures, equipment, and test methods for capital and disposable products.

Ensure execution of process and equipment validation (IQ/OQ/PQ, MSA) in compliance with FDA QSR, GMP, and ISO 13485.

Partner with PMO to manage schedules, resources, risks, and timelines; proactively identify opportunities to accelerate launches.

Lead pilot builds, early production runs, and transitions to Operations.





Provide leadership for technical issue resolution, including NCs, CAPAs, yield loss, and early production challenges.

Engage suppliers and Contract Manufacturers to support development, qualification, and manufacturing transfer.

Ensure completion and compliance of manufacturing documentation (work instructions, BOMs, routings, PFMEAs, control plans).

Track NPI performance metrics (yield, scrap, readiness, cost) and drive continuous improvement across launches

Required Qualifications

BS. in Industrial, Mechanical, Manufacturing Engineering, or related field.

7+ years of medical device manufacturing and NPI experience, including disposable/single-use products; capital equipment experience preferred.

Advanced English

Previous supervisory or team-lead experience

Strong knowledge of FDA QSR, GMP, and ISO 13485.

Proven experience leading cross-functional NPI programs in a regulated environment.

Experience with high-volume manufacturing.

Strong analytical, problem-solving, and communication skills.

Proficiency with Microsoft Office, Minitab, and CAD tools (SolidWorks/AutoCAD).

Desired Qualifications

Lean Six Sigma Green Belt or higher.

Experience with extrusion, injection molding, ultrasonic welding, tubing/sets, or electro‑mechanical assemblies.

Strong DFM/DFA and cost optimization background.

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📌 Manufacturing Engineer, NPI Lead (Centro-Norte)
🏢 Outset Medical
📍 Centro-Norte