Sr. Design Quality Engineer- Service

Sr. Design Quality Engineer
- Service (Contract)

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 to revolutionize robotic surgery. Our team brings experience from leading healthcare companies and is committed to delivering innovative quality solutions that meet FDA and international regulatory standards.

Join our Quality team to drive innovation and product leadership in medical robotics. We are hands-on, technical, solution-oriented, and accountable, using a data-driven approach to tackle challenges. We strive for continuous improvement through agile quality management systems and collaboration with cross-functional teams.

This contract role is responsible for ensuring product quality throughout the design lifecycle while serving as a liaison between Engineering and the Service organization. The position emphasizes design robustness, field performance improvement, and customer satisfaction by incorporating serviceability, reliability, and field feedback into product development.

• Act as the primary quality liaison to the Service organization.
• Support Design for Reliability (DFR), Design for Manufacturability (DFM), and Design for Serviceability (DFS) initiatives.
• Review hardware and system-related verification and validation strategies for the Service organization and ensure timely execution.
• Co-develop the project process validation strategy and review IQ/OQ/PQ/TMV protocols for service tools, equipment, software, and field processes.
• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management.
• Serve as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.
• Review test plans and test cases based on product and component-level requirements, ensuring appropriate statistical techniques are applied.
• Review and approve V&V system maintenance such as reworks and modification tracking.
• Partner with cross-functional teams to perform root cause analysis of design issues and implement corrective and preventive actions using NC and CAPA systems.
• Support field service engineering requests and assess serviceability risks.
• Collaborate with PMO to apply project management tools to define deliverables and establish a project schedule.
• Foster a culture of quality by sharing best practices and promoting quality awareness.

• BS in Engineering or Technology (Mechanical, Industrial, Electrical, Life Sciences, etc.).
• Minimum of 4 years of engineering experience with a BS in medical device or similarly regulated industry, or minimum of 2 years with a PhD.
• Preferred 2 years of experience in a development quality engineering function in a regulated environment.
• Experience in meeting Design Control and DHF requirements with R&D teams.
• Experience with Quality Management System to meet US FDA and ISO/MDR requirements.
• Experience with Risk Management, FMEA, Hazard Analysis, and GD&T requirements.
• Statistical skills to define sample size and data analysis techniques.
• Proficiency with Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems.
• Self-starter, team builder, and excellent verbal and written communication skills.
• Preferred:
  Experience in a clinical setting and/or field service.
• Preferred:
  Certifications such as CQE, CQA(BM), CQM, Six Sigma, etc.

Pay Transparency

The pay range for this position is $70 - $90 USD. 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 work approach (remote, hybrid, field, or office where applicable). Actual pay will be adjusted based on skills, experience, education, and other factors as permitted by law.

Total compensation may include additional incentives.

• Comprehensive health insurance (Medical, Dental, Vision) + HSA and FSA options
• Equity & Bonus Program
• Life Insurance 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
• Learning & Development Opportunities:
  On-demand online training and book reimbursement
• Team building and company events

Noah Medical may offer remote, hybrid, or onsite work arrangements within California depending on the team and role.

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to an inclusive environment. Applicants are considered for all positions without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic…