Manufacturing Engineer - NPI Lead

Responsibilities

• Lead and supervise NPI and 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
• Develop and scale manufacturing processes, tooling, fixtures, equipment, and test methods
• 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
• Lead pilot builds, early production runs, and transitions to Operations
• Provide leadership for technical issue resolution, including NCs, CAPAs, and yield loss
• Engage suppliers and Contract Manufacturers to support development and manufacturing transfer
• Ensure completion and compliance of manufacturing documentation including work instructions, BOMs, and PFMEAs
• Track NPI performance metrics such as yield, scrap, readiness, and cost

Requirements

• S. in Industrial, Mechanical, Manufacturing Engineering, or related field
• 7+ years of medical device manufacturing and NPI experience
• Experience with disposable/single-use products
• Advanced English fluency
• Previous supervisory or team-lead experience
• Strong knowledge of FDA QSR, GMP, and ISO 13485
• Experience with high-volume manufacturing
• Proficiency with Microsoft Office, Minitab, and CAD tools (SolidWorks/AutoCAD)

Preferred 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

About the Company

Outset is a trailblazing medical device company revolutionizing the field of dialysis through groundbreaking technology designed to reduce cost and complexity for patients and providers.