Lead Product Safety Engineer - Ultrasound

GE HealthCare UK

State College, , United States
Product safety standards compliance
Iso 14971 risk management
Iec 60601 series expertise
Ensure safety and regulatory compliance of GE HealthCare Ultrasound Probes throughout the product lifecycle

Job Summary

  • Ensure safety and regulatory compliance of GE HealthCare Ultrasound Probes throughout the product lifecycle.
  • Partner with cross-functional teams to drive robust safety engineering practices and safeguard patient safety.
  • Lead product safety interactions with Notified Bodies and drive resolution of safety-critical issues.

Matching Summary

Ensure safety and regulatory compliance of GE HealthCare Ultrasound Probes throughout the product lifecycle.

Skills & Requirements

Must-have

  • Product safety standards compliance
  • ISO 14971 risk management
  • IEC 60601 series expertise
  • Cross-functional team leadership
  • Product lifecycle safety assurance

Nice-to-have

  • Medical ultrasound experience
  • GE HealthCare QMS familiarity
  • Proactive regulatory interpretation
  • Mentoring and technical guidance

Key Requirements

  • Bachelor's degree in engineering or related field
  • 5+ years medical device development experience
  • 10+ years medical device engineering/compliance
  • 3 years IEC compliance and safety testing
  • Demonstrated IEC 60601 expertise
  • Strong ISO 14971 working knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter