Remedy Robotics
medical devices
ManufacturingLead
Neural analysis suggests this role is
optimal for Senior candidates.
“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
Full Job Description
ABOUT REMEDY ROBOTICS Cardiovascular disease is the #1 cause of morbidity and mortality in the world. Much of this could be prevented with better access to specialist care. Take stroke as an example: any delay in treatment can lead to permanent disability or death. However, due to a lack of specialist surgeons, the most effective intervention can only be performed in 2% of US hospitals. For patients who present to one of the 98% of hospitals that do not offer the surgery, treatment is either significantly delayed or not offered at all because timely transfer is not feasible. Our mission is to bring state-of-the-art vascular intervention to anyone, anytime, regardless of their location. Our team of medical clinicians, roboticists, and machine learning experts are working to bridge this gap by building the world’s first remotely-operated, semi-autonomous endovascular surgical robot. We’ve already done what nobody else could—using our system, doctors from around the world were able to remotely perform this procedure from as far as 8000 miles away. We now need your help to bring this technology out of the laboratory and into hospitals everywhere. THE ROLE You'll own the path from finished design to manufacturable product across both Remedy's single-use disposables and the surgical robot itself. You'll qualify suppliers, run design transfer, validate processes, and build the manufacturing records needed for our IDE submission and beyond. This is a hands-on role with growing scope — you'll personally write the early SOPs and validation protocols, then grow a team as the product matures. YOU WILL - 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 - Run process validation (IQ/OQ/PQ) and build the manufacturing records required under ISO 13485 - Qualify and manage relationships with contract manufacturers
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