Software Design Quality Engineer

Philips

Hybrid
12 years experience in software quality or reliability
Medical device industry background required
Expertise in iso 13485 and iec 62304 standards
This role involves setting Quality and Reliability targets for IGT Systems medical software to ensure high quality and outstanding reliability

Job Summary

  • This role involves setting Quality and Reliability targets for IGT Systems medical software to ensure high quality and outstanding reliability.
  • The engineer will validate key design inputs including safety, security, privacy, and usability while facilitating failure mode and effect analysis.
  • Candidates must be well-versed in global medical device regulations such as 21CFR820, EU MDR, and ISO 14971 to guide cross-functional teams.

Matching Summary

This role involves setting Quality and Reliability targets for IGT Systems medical software to ensure high quality and outstanding reliability.

Skills & Requirements

Must-have

  • 12 years experience in software quality or reliability
  • Medical device industry background required
  • Expertise in ISO 13485 and IEC 62304 standards
  • Strong knowledge of Design Controls and Risk Management
  • Experience leading FMEA activities for new products

Nice-to-have

  • Software testing experience is an added advantage
  • Statistical data analysis and regression modeling skills
  • Ability to inspire quality excellence culture
  • Experience with post-market analytics and field actions

Key Requirements

  • Bachelor's degree with 12 years experience or Master's with 10+ years
  • Experience in Software Engineering or Reliability Engineering within medical/aerospace sectors
  • Proficiency in reviewing DHF and DMR documents
  • Understanding of 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304, and ISO 14971

Work Rights

Not specified

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