Lead Product Safety Engineer - Ultrasound

About this role

<h1><b><b><b>Job Description Summary</b></b></b></h1>The Lead Product Safety Engineer is responsible for ensuring the safety and regulatory compliance of products within the GE HealthCare Ultrasound Probes organization. This role ensures that safety requirements are defined, implemented, and verified throughout all phases of the product lifecycle. The Lead Product Safety Engineer partners closely with design engineering, risk management, quality, regulatory, and manufacturing teams to drive robust safety engineering practices, safeguard patient safety, and ensure compliance with product safety standards.<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1><b>Job Description</b></h1><h2>Roles and Responsibilities</h2><ul><li><p>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.</p></li><li><p>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.</p></li><li><p>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.</p></li><li><p>Own the definition, flowdown, and verification of product safety requirements, ensuring they are appropriately incorporated during concept development, requirements definition, architecture decisions, NPI, design chang

Apply for this role on GE HEALTHCARE’s official careers site.