Lead manufacturing engineering for complex electromechanical medical-device assemblies, including contract-manufacturer relationships, manufacturing transfers, DFM/DFA, tooling, documentation, pilot builds, process validation, production readiness, and ramp activities. Drive improvements in quality, yield, delivery, capacity, cycle time, and cost while coordinating with R&D, Operations, Supply Chain, Quality, and external partners. The role is onsite in San Mateo and requires domestic and international supplier travel.
About Mendaera, Inc.
Mendaera is developing technology that will enable all healthcare providers to do more for their patients. Our platform combines real-time imaging, robotics, and artificial intelligence to make precise and consistent intervention more accessible. Our aim is to eliminate barriers in the patient journey, accelerate recovery, delight customers, and reduce cost of care.
About the Opportunity
As a Staff Manufacturing Engineer, you will lead manufacturing engineering for the internal production of complex electromechanical assemblies and drive partnerships with our external manufacturing network. This role will own the technical relationship with existing contract manufacturers and lead the identification, qualification, and onboarding of new manufacturing partners. This engineer will develop, transfer, and continually improve robust, scalable manufacturing processes for our capital equipment, and partner with R&D, Operations, Supply Chain, and Quality to achieve production goals across quality, delivery, cost, and scale.
What You’ll Do
- Own the technical relationship and manufacturing performance of contract manufacturing partners.
- Plan and execute manufacturing transfers between internal production and external partners, as well as between contract manufacturing sites.
- Partner with R&D early in product development to drive DFM/DFA, define manufacturing strategies, and ensure new assemblies are ready for external production.
- Develop and transfer complete manufacturing packages, including process flows, work instructions, routings, and inspection plans
- Develop and transfer custom tooling and fixtures to support assembly
- Lead pilot builds, process characterization, validation (IQ/OQ/PQ), production readiness reviews, and manufacturing ramp activities.
- Establish clear transfer plans, schedules, risks, deliverables, and acceptance criteria to ensure continuity of supply and successful production handoffs.
- Drive improvements in quality, yield, delivery, capacity, cycle time, and cost across the external manufacturing network.
- Define and monitor manufacturing performance metrics, identify emerging risks, and ensure timely escalation and resolution of issues.
- Collaborate across R&D, Operations, Quality, Supply Chain, and external partners to align technical requirements and drive manufacturing decisions.
Desired Skills & Experience
- Bachelor’s degree in mechanical engineering, manufacturing engineering, electrical engineering, or a related technical field.
- 8+ years of experience in manufacturing engineering, NPI, industrialization, supplier manufacturing, or a related discipline.
- Demonstrated experience transferring complex electromechanical assemblies between internal production and contract manufacturing sites.
- Experience identifying, evaluating, qualifying, and onboarding contract manufacturers or other strategic manufacturing partners.
- Strong knowledge of electromechanical assembly, production tooling, fixtures, test equipment, inspection methods, and manufacturing process controls.
- Experience developing and transferring manufacturing documentation, including assembly procedures, process flows, routings, inspection plans, PFMEAs, control plans, and training materials.
- Experience leading pilot builds, production readiness reviews, process validation, and manufacturing ramp activities.
- Strong working knowledge of DFM/DFA, root-cause analysis, corrective action, process capability, and statistical process control.
- Ability to lead complex, cross-functional manufacturing projects with limited oversight and drive decisions across R&D, Operations, Supply Chain, and Quality.
- Experience with Linux and software for manufacturing
- Strong written and verbal communication skills, including the ability to communicate technical requirements and risks clearly across internal teams and external partners.
- Experience manufacturing FDA-regulated medical devices or other products in a highly regulated industry.
Position Logistics
- This position is required to be on-site at Mendaera HQ in San Mateo.
- Travel to visit suppliers and contract manufacturers domestically and internationally will be required.
- The annual salary range for this position is $140,000 to $180,000.
- Mendaera offers comprehensive medical, dental, and vision coverage, as well as a 401k with a company match.
Mendaera, Inc. San Carlos, California, USA Office
San Carlos, CA, United States
Similar Jobs
Aerospace • Hardware • Robotics • Software • Manufacturing
Provide design-for-manufacturing feedback to structures teams, support prototype and flight builds, cover shop floor assembly work, clear production barriers, drive cross-work-center process improvements, and create standardized work instructions, specifications, and best practices to scale primary structure manufacturing for Terran R.
Top Skills:
DrillingFasteningGd&TJoiningMachiningTrim Operations
Aerospace • Hardware • Robotics • Software • Manufacturing
Define and document manufacturing processes for avionics hardware and wire harnesses, run Manufacturing Readiness Reviews, support technicians through builds, provide DFM feedback, work with supply chain and quality on component procurement and inspection, and analyze process and yield data to drive continuous improvement and capacity planning.
Top Skills:
Avionics BoxesCatiaData Analysis/Visualization ToolsErp SystemsIpc StandardsNxPcbasPlm SystemsWire Harness FabricationZuken
Artificial Intelligence • Hardware • Robotics • Software
Own end-to-end manufacturing test readiness for product lines, develop automated test hardware and software, analyze manufacturing data, investigate production failures, and improve yield, test time, reliability, scalability, and product quality. Collaborate across hardware, software, product development, and manufacturing operations while maintaining software quality through code reviews and hardware-in-the-loop continuous integration.
Top Skills:
Continuous Integration (Ci)Hardware-In-The-Loop (Hil)Manufacturing Execution Systems (Mes)PythonTest Automation
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
