Base: $122,000 - $184,000; bonus/equity: not speci...
On-site
Design controls for new product development
Digital health software applications
Iec62304 and iec82304
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
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.
Contributes to and manages digital health projects with the ability to provide clear/concise executive summaries on overall health of projects.
We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members.
Matching Summary
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
design controls for new product development
digital health software applications
IEC62304 and IEC82304
conducting internal and external audits
leading/supporting CAPAs, NCRs
risk management within design phase
Nice-to-have
building AI agents
creating dashboards using JIRA
statistical analysis for sample sizes
Key Requirements
Bachelor’s degree in engineering with minimum of 5 years of experience OR a Master's degree in engineering with minimum of 3 years of experience