Sw Product Quality Engineer

Philips

**
Software quality plans aligned with mr qms
Iec 62304 iec 14971 iso 13485 standards
Software fmea and hazard analysis execution
** Philips seeks a Software Product Quality Engineer to ensure quality in design across its MR software products throughout their lifecycle. The role involves hands-on support for software quality engineering, risk management, and regulatory compliance, primarily in a regulated medical device environment. **

Job Summary

  • This role is accountable for enabling Quality in Design across MR software products throughout the full lifecycle to ensure safe and compliant deliverables.
  • The engineer will validate key software design inputs including usability, reliability, performance, safety, security, privacy, serviceability, sustainability, and cost.
  • Candidates must possess strong written and verbal communication skills to clearly articulate technical and quality topics to diverse stakeholders.

Matching Summary

Match Score: 75

** Philips seeks a Software Product Quality Engineer to ensure quality in design across its MR software products throughout their lifecycle. The role involves hands-on support for software quality engineering, risk management, and regulatory compliance, primarily in a regulated medical device environment. **

Skills & Requirements

Must-have

  • Software Quality Plans aligned with MR QMS
  • IEC 62304 IEC 14971 ISO 13485 standards
  • Software FMEA and hazard analysis execution
  • Design History File DHF documentation review
  • Regulatory submission and audit support experience

Nice-to-have

  • Agile development practices in regulated environment
  • Strong stakeholder management and collaboration skills
  • Data analytics and intelligent analytics usage
  • Cross-site global team support capability
  • Risk-based thinking for quality decisions

Key Requirements

  • Bachelor's degree in Engineering with 8-12 years experience
  • Master's degree with 6-10 years experience
  • Hands-on experience in regulated industry (medical devices)
  • Working knowledge of 21 CFR 820 and ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter