Staff Capital Sustaining Manufacturing Engineer

Staff Capital Sustaining Manufacturing Engineer

San Jose, California

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, Med robotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

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.

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.

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 Solid Works 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.

Self-directed,…