Manufacturing Lead

Manufacturing Lead Remedy Robotics San Francisco, CA Job Details Full-time 22 hours ago Qualifications Manufacturing management Startup experience ISO standards Regulatory submissions Manufacturing engineering Manufacturing company experience FDA regulations Engineering 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, molders, and component suppliers Drive DFM/DFA feedback into engineering early, before designs lock Define and track manufacturing

KPIs:

yield, cost, lead time, defect rates Author the manufacturing sections of the IDE submission Build a small manufacturing/operations team as volume scales You 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 Strong communication with engineering — you give early, useful DFM feedback rather than reviewing finished designs BS or MS in mechanical engineering, manufacturing engineering, or related field Nice to Haves 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