Manufacturing Engineer -NPI Lead
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).
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.
Company Culture
At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career.
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 individuals and teams.
Privacy is important to us. Please review our Applicant Privacy Notice.
Important Notice
We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at peopleops@outsetmedical.com.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT
Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.