Qualifications

• 8+ years of hands-on manufacturing engineering or operations leadership in medical devices
• Direct experience taking a Class II or III device from R&D through production
• Fluency with design transfer and process validation (IQ/OQ/PQ)
• Experience managing contract manufacturers at a startup scale
• Comfort being hands-on now and building a team later
• Strong communication with engineering for early DFM feedback
• BS or MS in mechanical engineering or related field

Responsibilities

• Own design transfer for disposable accessories including injection molding and packaging
• Own design transfer for the surgical robot including supplier qualification and assembly design
• Run process validation and build manufacturing records under ISO 13485
• Qualify and manage relationships with contract manufacturers and suppliers
• Drive DFM/DFA feedback into engineering early in the design phase
• Define and track manufacturing KPIs like yield and defect rates
• Author the manufacturing sections of the IDE submission
• Build and lead a manufacturing/operations team as production scales

Benefits

• Opportunity to directly influence product development and manufacturing processes
• Hands-on role with significant initial involvement before team leadership
• Experience with Class II or III devices adds valuable industry exposure
• Growing role in a startup environment with potential for significant impact
• Dynamic responsibilities that span both disposables and robotic systems