Senior Design Quality Engineer-ME/EE

Summary

Join Noah Medical's Quality team as a Sr. Design Quality Engineer, providing technical guidance and leadership throughout product development. You will establish design requirements, review verification and validation strategies, participate in design reviews, and serve as a technical resource for risk management. Responsibilities include reviewing test plans, approving V&V system maintenance, collaborating on root cause analysis, supporting field service requests, and partnering with cross-functional teams. The ideal candidate possesses a BS in Engineering or Technology with 4+ years of experience in the medical device industry or a PhD with 2+ years of experience. This full-time salaried position offers a comprehensive benefits package and a flexible work approach.

Requirements

• BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc
• Minimum of 4 years of Engineering work experience with a BS in the medical device or similarly regulated industry or minimum of 2 years of Engineering work experience with a PhD
• 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, GD & T requirements
• Experienced with statistical skills to define/train on test sample size and data analysis techniques
• Use Design For Manufacturability, Assembly and Service-ability principles to reduce the cost, simplify assembly and serviceability
• Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems
• Must be a self-starter, team builder, and excellent in verbal and written communication

Responsibilities

• Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation
• Review hardware and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy
• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management
• Serves 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 upon the product and component level requirements ensuring that appropriate statistical techniques are applied
• Review and approve V&V system maintenance such as reworks and modification and tracking
• Partner with cross-functional teams to collaborate on root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities
• Support field service engineering requests and assess serviceability risks
• Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule
• Foster a culture of quality throughout the organization by sharing best practices and promoting quality awareness
• Participate in clinical labs, formative and summative human factors studies to ensure product safety, usability, and regulatory compliance

Preferred Qualifications

• Preferred 2 years experience in a development QE function in a regulated environment
• Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc

Benefits

• 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, 15-20 days of PTO + 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