Lead Product Safety Engineer - Ultrasound
GE HealthCareHighlight
Summary
About the Role
About You
- Bachelor’s degree in engineering, physics, or related technical discipline and 5+ years of medical device development experience; OR 10+ years in medical device engineering/compliance with at least 3 years of hands-on IEC compliance and safety testing experience.
- Demonstrated expertise in IEC 60601 series, IEC 60601-2-37, IEC 60529, and other applicable medical electrical equipment standards.
- Strong working knowledge of ISO 14971, including experience leading or contributing to formal device risk management activities.
- Proven ability to lead cross-functional teams, influence technical decisions, and communicate complex safety concepts across diverse technical and cultural environments.
- Experience in medical ultrasound, diagnostic imaging systems, or related high-reliability medical devices.
- Familiarity with GE HealthCare’s QMS, design control processes, and product development workflows.
- Demonstrated ability to manage multiple priorities, drive complex technical issues to closure, and make sound safety-critical decisions under time constraints.
- Strong analytical, troubleshooting, and problem-solving skills, with the ability to distill complex information into clear technical documentation.
- Excellent written and verbal communication skills, including the ability to author safety justifications, risk-benefit analyses, and regulatory documentation.
Benefits
- Great work environment and professional development opportunities.
- Challenging careers with competitive compensation.
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE HealthCare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity and we work to create a world where healthcare has no limits.