Base: $122,000 - $184,000; bonus/equity: not speci...
Fda design controls
Digital health software applications
Iec62304 and iec82304
The primary role of a Senior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products
Job Summary
The primary role of a Senior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products.
Responsibilities include contributing to and managing digital health projects, providing advice/direction in quality related topics, and leveraging professional expertise to contribute to strategy and drive business results.
Employees scheduled to work 30 or more hours per week are eligible for benefits including comprehensive medical, vision, dental, and life insurance, as well as 401(k) and tuition assistance.
Matching Summary
The primary role of a Senior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products.
Salary
Base: $122,000 - $184,000; Bonus/Equity: Not specified; Benefits: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Skills & Requirements
Must-have
FDA design controls
digital health software applications
IEC62304 and IEC82304
internal and external audits
leading CAPAs, NCRs
risk management within design phase
Nice-to-have
strong emotional intelligence
expert negotiation skills
building AI agents
statistical analysis for sample sizes
Key Requirements
Bachelor's degree in engineering with minimum 5 years experience OR Master's degree with minimum 3 years experience