About The TeamThe 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.
- Self-directed, organized, detail-oriented, and comfortable managing multiple priorities in a fast-paced, evolving environment.
- Demonstrated ability to mentor others and lead technical execution through influence rather than formal authority.
#LI-Onsite
Pay TransparencyThe Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules.
Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.California Pay Range
$139,000-$174,000 USD
Benefits & Perks (For Full Time Employees):- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
- Equity & Bonus Program
- Life Insurance (company paid & supplemental) and Disability insurance
- Mental health support through medical insurance programs
- Legal and Pet Insurance
- 12+ paid holidays, Flexible Time Off + Sick Time
- Paid parental leave
- In-office snacks and beverages
- In-office lunch stipend
- Learning & Development Opportunities: On-demand online training and book reimbursement
- Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
