Senior Clinical Engineer – Ro & Gip

GE Healthcare GE Healthcare · Healthcare · United States +1 · Remote · Engineering / Technology

This role focuses on the clinical development of imaging products and Software as a Medical Device (SaMD) within GE HealthCare's MIM Software business. The Senior Clinical Engineer will translate clinical needs into functional requirements, support V&V testing, and contribute to regulatory submissions and product lifecycle planning. The role requires a strong understanding of molecular imaging SaMD experience and collaboration with cross-functional teams.

What you'd actually do

  1. Support the clinical development of imaging products, diagnostics, and Software as a Medical Device by helping determine safety, effectiveness, and clinical value.
  2. Translate clinical and customer needs into functional requirements that inform product development.
  3. Contribute to software prototyping, support verification and validation (V&V) testing, and help drive iterative improvements following product launch.
  4. Lead and contribute to cross-functional initiatives that support product success, including work related to: - Product roadmap execution and product lifecycle planning - Software as a Medical Device regulatory submissions (such as 510(k)) - Sponsored research agreements
  5. Build and maintain technical and clinical expertise within your area through activities such as: - ​Reviewing scientific literature - Conducting customer interviews - Attending conferences - Visiting clinical sites

Skills

Required

  • Bachelor’s degree in Biomedical Engineering, Radiologic Technology or Radiologic Sciences, Computer Science, Medical Physics, or a related discipline
  • 3+ years of molecular imaging Software as a Medical Device experience OR 5+ years of closely related adjacent experience
  • Strong problem-solving and analytical skills
  • Ability to communicate and collaborate effectively with clinical professionals, engineering, regulatory, quality, and other cross-functional internal teams
  • Demonstrated ability and aptitude to build clinical, anatomical, and technical domain knowledge
  • Willingness to travel periodically for medical conferences, customer meetings, and site visits
  • Legal authorization to work in the U.S. without current or future visa sponsorship

Nice to have

  • Master’s degree or PhD in a relevant field
  • Prior experience in the software or medical device industry; strong familiarity with design controls and regulatory submissions
  • Direct experience with imaging software
  • Strong technical writing skills
  • Strong communication skills, including the ability to tailor messages for both technical and non-technical audiences, explain complex concepts clearly and concisely, and communicate progress and risks effectively to non-technical stakeholders
  • Experience working successfully in team-based environments
  • Project management skills, including planning, documentation, and execution
  • Experience mentoring junior engineers, delegating appropriately, and supporting team growth
  • Recognized depth of expertise in advanced molecular imaging software

What the JD emphasized

  • Software as a Medical Device
  • molecular imaging Software as a Medical Device experience
  • Legal authorization to work in the U.S. is required.
  • Legal authorization to work in the U.S. without current or future visa sponsorship