Manufacturing Lead

Remedyrobotics
San Francisco, US
On-site

Who this role is best for

Best suited to senior manufacturing engineers with medical device experience who thrive in startup environments and hands-on production scaling.

Best fit for

  • Senior manufacturing engineers with Class II/III medical device production experience.
    — “Proven experience leading Class II and/or Class III medical devices from R&D through production”
  • Candidates comfortable with both hands-on work and team scaling.
    — “Ability to operate effectively in a hands-on capacity while scaling and developing manufacturing teams over time”
  • Professionals adept at DFM/DFA and early-stage engineering feedback.
    — “Excellent cross-functional communication skills with a proactive approach to Design for Manufacturability (DFM)”

Things to consider

  • Must have experience with ISO 13485 compliance and documentation.
    — “maintenance of ISO 13485-compliant manufacturing documentation”
  • Requires managing contract manufacturers in fast-paced startup conditions.
    — “Demonstrated success managing contract manufacturers and component suppliers within fast-paced startup environments”

How to stand out

  • Highlight specific examples of design transfer success in medical devices.
    — “Strong expertise in design transfer, process validation (IQ/OQ/PQ)”
  • Showcase experience with disposable device manufacturing processes.
    — “Experience manufacturing disposable medical devices, including injection molding, sterile barrier packaging”
  • Quantify improvements in manufacturing KPIs from past roles.
    — “Define and improve manufacturing KPIs including yield, cost, lead time, and defect rates”
Pace · Fast PacedCollaboration · HighAutonomy · MediumDecision Impact · TeamLevel · Senior

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

  • successful design transfer
  • improved manufacturing KPIs
  • scalable manufacturing processes
Typical background
mechanical engineeringmanufacturing engineering

Skills & requirements

Required

Manufacturing EngineeringISO 13485Process ValidationMedical Device ManufacturingCross-functional Communication

Preferred

Disposable Medical DevicesElectromechanical ManufacturingFDA ComplianceLean ManufacturingSix Sigma

Stack & domain

Manufacturing EngineeringClass Ii And/or Class Iii Medical DevicesDesign TransferProcess ValidationIso 13485-compliant Manufacturing DocumentationContract ManufacturersComponent SuppliersDesign For Manufacturability (dfm)Fda InspectionsLean ManufacturingSix Sigma MethodologiesCross-functional CommunicationProactive ApproachTeam ScalingHands-on CapacityEarly-stage Engineering FeedbackMedical Device IndustryElectromechanicalCapital Equipment ManufacturingRegulated EnvironmentsLow-volume High-mix Production

About the role

Original posting from Remedyrobotics via Ashby

Remedy Robotics https://www.remedyrobotics.com/ is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location. Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others.

We are looking to hire a Manufacturing Lead for our Hardware Team.

What You’ll Do:

  • Lead manufacturing engineering from prototype through production for Remedy’s disposable instruments and surgical robotic system
  • Drive design transfer, DFM/DFA, supplier qualification, and production process development across molding, assembly, packaging, sterilization, and test fixturing
  • Execute manufacturing validation activities (IQ/OQ/PQ) and maintain manufacturing documentation required under ISO 13485 and for IDE submissions
  • Define and improve manufacturing KPIs including yield, cost, lead time, and defect rates
  • Build and scale Remedy’s manufacturing and operations team as the product matures

Knowledge, Skills, Abilities:

  • Proven experience leading Class II and/or Class III medical devices from R&D through production
  • Strong expertise in design transfer, process validation (IQ/OQ/PQ), and maintenance of ISO 13485-compliant manufacturing documentation
  • Demonstrated success managing contract manufacturers and component suppliers within fast-paced startup environments
  • Ability to operate effectively in a hands-on capacity while scaling and developing manufacturing teams over time
  • Excellent cross-functional communication skills with a proactive approach to Design for Manufacturability (DFM), providing early-stage engineering feedback throughout product development rather than after final design completion

Minimum Qualifications:

  • 8+ years of hands-on experience in manufacturing engineering and operations leadership within the medical device industry
  • Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field

Preferred Qualications:

  • Experience manufacturing disposable medical devices, including injection molding, sterile barrier packaging (ISO 11607), and EO or gamma sterilization validation
  • Experience developing or scaling catheter or guidewire assembly processes
  • Experience with electromechanical or capital equipment manufacturing in regulated environments
  • Experience supporting FDA inspections, audits, or regulatory compliance activities
  • Background in Lean Manufacturing or Six Sigma methodologies applied to low-volume, high-mix production environments

Source: Remedyrobotics careers (Ashby)

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