Software Design Assurance Eng

Philips

Bedford, MA, US
Base: $102,480 to $163,968; bonus/equity: not spec...
Fully onsite
Fda regulated environments
Iec 62304 medical device software
Risk management (iso 14971)
Philips is seeking a Software Design Assurance Engineer for their Bedford, MA location, focusing on software quality documentation and regulatory compliance in the medical device sector. The ideal candidate will have over five years of experience in FDA-regulated environments and possess strong knowledge of software design assurance processes

Matching Summary

Match Score: 85

Philips is seeking a Software Design Assurance Engineer for their Bedford, MA location, focusing on software quality documentation and regulatory compliance in the medical device sector. The ideal candidate will have over five years of experience in FDA-regulated environments and possess strong knowledge of software design assurance processes.

Salary

Base: $102,480 to $163,968; Bonus/Equity: Not specified; Benefits: Comprehensive Philips Total Rewards benefits program

Skills & Requirements

Must-have

  • FDA regulated environments
  • IEC 62304 medical device software
  • Risk Management (ISO 14971)
  • SDLC
  • Software V&V
  • Root Cause Analysis
  • Design for Quality (DfQ)

Nice-to-have

  • Agile
  • SAFe
  • ISTQB certification

Key Requirements

  • 5+ years' experience in FDA regulated, IEC 62304 medical device software environments
  • Bachelor’s Degree in Quality, Computer Science/Engineering or similar disciplines
  • US work authorization required
  • Must reside in or within commuting distance to Bedford, MA

Work Rights

Must have US citizenship

Tailored Resume

Cover Letter