Staff Design Quality Engineer- ME/EE
Skills
- Product and system design requirements development
- Verification and validation strategy planning and execution
- Design reviews and requirements traceability
- Risk management in compliance with ISO 14971 and IEC 60601
- Statistical analysis techniques for test sample size and data evaluation
- Human Factors collaboration
- Regulatory submission and audit support
- Project management coordination
- Quality management systems knowledge
- Use of Microsoft Office, Google Suite, Jama, ePLM/eQMS
Responsibilities
- Provide technical leadership on product and system design requirements, specifications, verification, and validation activities.
- Develop and implement hardware and system verification and validation strategies aligned with R&D objectives.
- Participate in design reviews, requirements analysis, tracing, and configuration management.
- Serve as technical resource for risk management activities compliant with ISO 14971 and IEC 60601.
- Review and approve test plans, test cases, and apply statistical methods for validation.
- Collaborate with Human Factors experts to assess device usability during development.
- Review and manage verification and validation system maintenance including reworks and modifications.
- Analyze root causes of design issues and manage corrective and preventive actions using NC and CAPA systems.
- Conduct audits of Design History Files and support internal and external audits.
- Support Regulatory Affairs with documentation and inquiry responses.
- Assist field service engineering with serviceability risk assessments.
- Coordinate with PMO on project deliverables and scheduling.
- Promote best practices in quality management and statistical techniques across the organization.
- Maintain compliance with Noah Medical Quality Management System and regulatory requirements.
Education
- Bachelor’s degree in Engineering or Technology (Mechanical, Industrial, Electrical, Life Sciences, or related fields)
Benefits
- Competitive salary
- Comprehensive health insurance including Medical, Dental, Vision, HSA and FSA options
- Equity and bonus programs
- Company paid life and disability insurance with supplement options
- Mental health support through insurance programs
- Legal and pet insurance
- 12+ paid holidays, 15-20 PTO days plus sick leave
- Paid parental leave
- In-office snacks, beverages, and lunch stipend
- Learning and development opportunities including online training and book reimbursement
- Team building and company social events
Average salary estimate
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Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. Based in Silicon Valley and backed by well-known institutional investors, ...
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