Manufacturing Engineer -NPI Lead

Requirements

• 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.
• Company Culture
• An opportunity at Outset Medical won't just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individ

Additional Information

Company Overview Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve "better" now, not some day. At Outset we're revolutionizing an industry and changing lives. We're impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We're giving providers time back to focus on patient care. And we're giving patients the power to take control of their life and get back to enjoying the things they love. Position Overview 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 S. 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).

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at outsetmedical? Share your experience