Not specified; competitive compensation offered; r...
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Iec 60601 series standards expertise
Iso 14971 risk management leadership
Ultrasound probe safety engineering
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GE HealthCare Technologies is seeking a Lead Product Safety Engineer for their Ultrasound Probes organization, responsible for ensuring product safety and regulatory compliance. The ideal candidate will have extensive experience in medical device engineering and safety standards, particularly related to ultrasound technology.
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Job Summary
The Lead Product Safety Engineer serves as the Subject Matter Expert for product safety of ultrasound probes, ensuring compliance with global safety standards.
This role requires leading interactions with Notified Bodies, managing safety document submissions, and representing the organization during audits and technical file reviews.
Candidates must possess a Bachelor's degree in engineering or physics along with significant medical device development experience to drive robust safety engineering practices.
Matching Summary
Match Score: 75
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GE HealthCare Technologies is seeking a Lead Product Safety Engineer for their Ultrasound Probes organization, responsible for ensuring product safety and regulatory compliance. The ideal candidate will have extensive experience in medical device engineering and safety standards, particularly related to ultrasound technology.
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Salary
Not specified; Competitive compensation offered; Relocation assistance provided
Skills & Requirements
Must-have
IEC 60601 series standards expertise
ISO 14971 risk management leadership
Ultrasound probe safety engineering
Notified Body audit representation
Cross-functional team collaboration
Nice-to-have
Medical ultrasound domain experience
GE HealthCare QMS familiarity
Strong analytical troubleshooting skills
Mentoring and training capabilities
Complex technical documentation authoring
Key Requirements
Bachelor's degree in engineering, physics, or related discipline
5+ years medical device development experience OR 10+ years total
Hands-on IEC compliance and safety testing experience