Senior/ Staff Capital Sustaining Manufacturing Engineer
Noah MedicalSan Jose, California, United States · Posted 9 days agoDescription
Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team
The Systems Manufacturing Engineering team is responsible for bringing complex capital robotic systems from design through manufacturing readiness, production, sustaining support, and field-service lifecycle management. The team partners closely with R&D, Quality, Regulatory, Operations, Supply Chain, Service, and Product teams to ensure that systems and accessories can be built, tested, released, maintained, and supported with strong quality and traceability.
A Day In The Life Of Our Senior/ Staff Capital Sustaining Manufacturing Engineer
- Provide day-to-day technical support for the assembly, integration, testing, troubleshooting, rework, and release of capital robotic systems, subsystems, and accessories.
- Troubleshoot complex mechanical, electrical, electromechanical, software-configured, and test-related manufacturing issues; identify root causes and implement effective corrective actions.
- Support production builds, build-at-risk activities, MRB dispositions, rework, repair, and retest while maintaining appropriate product and process traceability.
- Partner with Manufacturing Operations and technicians to resolve issues quickly while preserving GMP and quality-system requirements.
- Use production, test, complaint, service, and nonconformance data to identify recurring issues and prioritize improvements.
- Support transfer of capital-system designs from R&D into manufacturing, including manufacturing-readiness reviews, assembly methods, test methods, process flow, tooling, documentation, training, and line readiness.
- Develop, document, implement, and continuously improve manufacturing processes for capital systems and accessories.
- Author, review, and execute manufacturing documentation, including manufacturing process instructions, work instructions, test instructions, equipment and fixture specifications, protocols, reports, DHR content, and training materials.
- Develop and maintain process risk-management deliverables, including process FMEAs, control plans, process-flow documentation, and verification-of-effectiveness activities as appropriate.
- Plan and execute process verification and validation activities, including IQ/OQ/PQ or equivalent qualification and validation work, in partnership with Quality and Regulatory teams.
- Ensure manufacturing documentation is accurate, usable on the floor, revision-controlled, and aligned with approved drawings, specifications, bills of material, and quality-system requirements.
- Maintain traceability of part numbers, revisions, serial numbers, equipment, test results, and associated records throughout the manufacturing lifecycle.
About You
- Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related discipline; equivalent practical experience may be considered.
- Typically, 5+ years of experience in manufacturing engineering, process development, sustaining engineering, or a closely related function, including significant experience with complex electromechanical products.
- Demonstrated experience supporting capital equipment, medical devices, robotics, automation systems, or other complex hardware/software products in a regulated manufacturing environment.
- Strong hands-on troubleshooting experience with mechanical, electrical, electromechanical, and system-level assembly or test problems.
- Experience with design transfer, manufacturing readiness, process development, process validation, pFMEA, control plans, and manufacturing documentation.
- Working knowledge of change control and quality-system processes, including engineering changes, deviations, nonconformances, CAPA, and complaint or field-feedback integration.
- Working knowledge of FDA quality-system requirements, ISO 13485, GMP, and applicable process-validation expectations.
- Experience designing or implementing fixtures, tooling, test equipment, error-proofing, or semi-automated manufacturing solutions.
- Experience with PLM/QMS systems and controlled documentation; familiarity with Arena or similar systems is preferred.
- Proficiency with SolidWorks or equivalent CAD tools, Microsoft Office/Excel, and data-analysis methods.
- Strong written and verbal communication skills, with the ability to create precise technical documentation and influence cross-functional decisions.
Similar jobs
Company Overview Amperesand is reinventing how the world powers its most critical systems. We are facing a once-in-a-generation opportunity for infrastructure disruption. Electricity demand is skyrocketing, driven by AI…
Est. 105,000 USD
About Lucid At Lucid, we are creating exceptional mobility experiences through innovation to drive the world forward. Built on Lucid’s proprietary technology and software-defined vehicle architecture, our award-winning v…
Est. 115,000 USD
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century…
Est. 115,000 USD
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century…
Est. 124,000 USD
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, p…
Est. 105,000 USD
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trus…
Est. 115,000 USD
Step into a career with ASM, where cutting edge technology meets collaborative culture. For over 55 years ASM has been ahead of what’s next, at the forefront of innovation and what’s technologically possible. With more…
Est. 115,000 USD
fairlife, LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich and dairy products to nourish consumers. With over $3B in annual retail sales, fairlife’s portfolio of delicious, lactose-free…
Est. 115,000 USD
At Zone 5 Technologies, we're redefining what's possible in unmanned aircraft systems. Our team of engineers and innovators is developing cutting-edge autonomous solutions that push the boundaries of UAS technology - sol…
Est. 115,000 USD
Gotion Inc. is based in Silicon Valley, CA, currently building a Manufacturing facility in Manteno, IL and has R&D centers in Ohio, China, Japan and Europe. We innovate in the next generation electric vehicle and ene…
Est. 80,000 EUR
Maybell Quantum is growing quickly, and we are expanding our technical group in Finland! If joining an outstanding team at one of the most exciting companies in quantum computing sounds interesting, then Maybell may be t…
Est. 95,000 USD
Standard Nuclear is fueling America’s nuclear renaissance at industrial scale. Our mission is to deliver the essential building blocks of nuclear power—enabling cost-effective, safe, and secure energy for the world. The…
Est. 60,000 USD
Manufacturing Engineering Intern Location: Burlingame, CA Department: Manufacturing Engineering Reports To: Manufacturing Equipment Engineering Manager Position Type: Internship (3, 6, or 9 months available) Start date f…
Est. 95,000 USD
Standard Nuclear is fueling America’s nuclear renaissance at industrial scale. Our mission is to deliver the essential building blocks of nuclear power—enabling cost-effective, safe, and secure energy for the world. The…
Est. 125,000 USD
Voyager is an innovative defense, national security, and space technology company committed to advancing and delivering transformative, mission-critical solutions. We tackle the most complex challenges to unlock new fron…
Est. 105,000 USD
Step into a career with ASM, where cutting edge technology meets collaborative culture. For over 55 years ASM has been ahead of what’s next, at the forefront of innovation and what’s technologically possible. With more…
Est. 140,000 USD
Divergent is building the new industrial age. Every day, our teams design, manufacture, and assemble advanced systems for some of the world’s most demanding industries. Our integrated engineering and manufacturing platfo…
Est. 95,000 USD
Standard Nuclear is fueling America’s nuclear renaissance at industrial scale. Our mission is to deliver the essential building blocks of nuclear power—enabling cost-effective, safe, and secure energy for the world. The…
Est. 115,000 USD
Company Overview Amperesand is reinventing how the world powers its most critical systems. We are facing a once-in-a-generation opportunity for infrastructure disruption. Electricity demand is skyrocketing, driven by AI…
Est. 115,000 USD
At Senra Systems, we believe that the future of manufacturing lies not in automation, but in configuration. We supercharge electrical wire harness manufacturing through software configuration, transforming skilled assemb…
Est. 140,000 USD
SENIOR DESIGN ENGINEER (ADVANCED ENERGY HARDWARE) Freeform builds AI-native manufacturing systems that unify software, hardware, and physics to produce industrial-scale parts at the speed of human ideation. By treating m…
Est. 115,000 USD
Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, we serve critical industries such as defense, aerospace, a…
Est. 115,000 USD
About Lucid At Lucid, we are creating exceptional mobility experiences through innovation to drive the world forward. Built on Lucid’s proprietary technology and software-defined vehicle architecture, our award-winning v…
Est. 95,000 USD
Gotion Inc. is based in Silicon Valley, CA, currently building a Manufacturing facility in Manteno, IL and has R&D centers in Ohio, China, Japan and Europe. We innovate in the next generation electric vehicle and ene…
Est. 185,000 USD
Turning Space into a Transportation Layer for EarthWho We Are: Inversion builds advanced reentry systems to deliver next-generation capabilities from space. Our mission is to make Earth radically more accessible by turni…
Est. 110,000 USD
Role Automation Engineer Location Sacramento, CA Department Manufacturing Reports To Head of Automation Position Type Full-time About Peak Energy Peak Energy Technologies is the first American venture to advance globally…
Est. 115,000 USD
Join Axon and be a Force for Good. At Axon, we’re on a mission to Protect Life. We’re explorers, pursuing society’s most critical safety and justice issues with our ecosystem of devices and cloud software. Like our produ…
Est. 124,000 USD
About the Company General Matter is enriching uranium in America. Our goal is to design, build, and operate the world’s lowest-cost enrichment services in the United States. Our mission is to restore America’s ability to…
Est. 115,000 USD
Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, we serve critical industries such as defense, aerospace, a…
Est. 175,000 USD
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, p…