Serve as a Subject Matter Expert (SME) and local technical authority for product safety of ultrasound probes, following and sharing best practices, and supporting global consistency across programs.
Partner with the Safety & Risk Engineer and the local Install Base Engineer to apply ISO 14971 throughout the product lifecycle, covering hazard identification, risk analysis, risk control strategies, benefit‑risk justification, and final safety sign‑off. Maintain and update product Cause & Mitigation Tables (CMT) to ensure all mitigations remain effective and implemented, incorporating post‑market feedback and periodic review inputs in a timely manner.
Lead product‑safety‑related interactions with Notified Bodies (NB), including owning safety document submissions, preparing technical safety justifications, responding to NB questions or nonconformities, and representing product safety as a SME during NB audits and technical file reviews.
Own the definition, flowdown, and verification of product safety requirements, ensuring they are appropriately incorporated during concept development, requirements definition, architecture decisions, NPI, design changes, and sustaining activities.
Act as the local expert for IEC 60601‑2‑37, IEC 60601‑1, IEC 60601‑1‑2, and related ultrasound safety standards, providing authoritative interpretation and ensuring compliance across design and verification activities.
Drive resolution of safety‑critical issues, including investigation of safety escalations, evaluation of field data, review of design changes, and leadership of cross-functional safety assessments and safety‑impact decisions.
Provide safety engineering leadership for audits, inspections, design reviews, and regulatory submissions, ensuring safety documentation is complete, accurate, and compliant with global regulatory expectations.
Mentor and develop engineers and support personnel, building safety engineering capability through training, coaching, and technical guidance on standards, safety analyses, and test methodology.
Monitor and interpret evolving global regulations and safety standards, assessing their impact on product development and work proactively with the Safety & Risk Engineer to integrate new requirements into organizational processes and designs.
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.
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We will not sponsor individuals for employment visas, now or in the future, for this job opening.GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
Skills Required
- Bachelor's degree in engineering, physics, or related technical discipline
- 5+ years of medical device development experience
- Demonstrated expertise in IEC 60601 series and related standards
- Strong knowledge of ISO 14971 and risk management activities
- Proven ability to lead cross-functional teams and influence technical decisions
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
GE Healthcare Insights
What We Do
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.
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