Remedy Robotics
medical devices
ManufacturingLead
“Manufacturing Lead at Remedy Robotics. Skills: design transfer, process validation, vendor management, manufacturing operations. Own design transfer for the disposable accessories — injection molding, assembly, packaging, and sterilization. Own design transfer for the surgical robot — supplier qualification, assembly process design, test fixturing”
What You'll Achieve.
yield; cost; lead time; defect rates
Industry & Context.
DFM/DFA feedback
What They're Looking For.
Must Have
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, process validation (IQ/OQ/PQ), and ISO 13485 manufacturing records, Experience managing contract manufacturers and component suppliers at a startup scale, Comfort being hands-on now and building a team later, communication with engineering — you give early, useful DFM feedback rather than reviewing finished designs
Nice to Have
Disposable medical device experience — injection molding, sterile packaging (ISO 11607), EO or gamma sterilization validation, Catheter or guidewire assembly process experience, Electromechanical/capital equipment manufacturing experience, Prior FDA inspection or audit experience, Lean or Six Sigma background applied to small-volume, high-mix production
What You'll Do.
Own design transfer for the disposable accessories — injection molding
Own design transfer for the surgical robot — supplier qualification
assembly process design
Run process validation (IQ/OQ/PQ) and build the manufacturing records required under ISO 13485
Qualify and manage relationships with contract manufacturers
and component suppliers
Drive DFM/DFA feedback into engineering early
Author the manufacturing sections of the IDE submission
Build a small manufacturing/operations team as volume scales
How You'll Work.
Team & Collaboration
communication with engineering
Communication Scope
communication with engineering
Process & Methodology
design transfer, process validation
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