Manufacturing Engineer -NPI Lead

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. 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.

Requirements

• 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).

Benefits

• Competitive salary
• Benefits package
• Opportunities for professional growth and development