Senior Clinical Engineer - Theranostic/ Neuro

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

This role focuses on the clinical development of imaging products, drug products, diagnostics, and Software as a Medical Device (SaMD) within GE Healthcare's MIM Software business. The Senior Clinical Engineer will determine safety, effectiveness, and clinical value, translate clinical needs into requirements, support V&V testing, and contribute to product roadmapping and regulatory submissions. The role requires a Bachelor's degree and experience in molecular imaging SaMD or adjacent fields, with a strong emphasis on problem-solving and collaboration within multidisciplinary teams.

What you'd actually do

  1. Drive the clinical development of imaging products, drug products, diagnostics, and Software as a Medical Device (SaMD) by determining safety, effectiveness, and clinical value.
  2. Translate clinical and customer needs into functional requirements, contribute to software prototyping, support verification and validation (V&V) testing, and enable post-market iterative improvements.
  3. Lead and contribute to cross-functional projects to ensure product success, including (but not limited to): SaMD regulatory submissions (e.g., 510(k)), Sponsored research agreements, Product roadmapping and lifecycle planning
  4. Develop and maintain in-depth technical and clinical expertise within your domain through scientific literature review, customer interviews, conference attendance, and clinical site visits.
  5. Apply strong understanding of key business drivers to execute strategy and deliver results; recognize how your work integrates with other teams and supports broader organizational goals.

Skills

Required

  • Bachelor's degree from an accredited university or college with an applicable field of study (e.g., Biomedical Engineering, Radiologic Technology/Sciences, Computer Science, Medical Physics)
  • 3+ years of molecular imaging SaMD experience or 5+ years of relevant adjacent experience
  • Strong problem-solving and analytical abilities
  • Ability to communicate and collaborate effectively with clinical professionals, engineering, regulatory, quality, and other multidisciplinary internal teams
  • Aptitude and demonstrated ability to build clinical, anatomical, and technical domain knowledge
  • Willingness to travel periodically to attend medical conferences, customer meetings, and site visits

Nice to have

  • Master's or PhD is a plus
  • Prior software or medical device industry experience is preferred, but not required
  • Strong self-initiative with a demonstrated growth mindset
  • Established project management skills, including planning, documentation, and execution
  • Ability to mentor junior engineers, delegate appropriately, and support team development
  • Investigates problems with intellectual curiosity and inquisitive passion
  • Demonstrated ability to analyze complex problems and resolve them effectively
  • Strong oral, written, and technical communication skills
  • Direct experience with PET and SPECT imaging software
  • Deep understanding of quantitative imaging, particularly in Theranostic applications
  • Recognized Subject Matter Expert (SME) in advanced molecular imaging software
  • Major contributor to: Regulatory audits, FDA software clearance activities
  • Experience with verification and validation (V&V) activities
  • Strong technical writing skills
  • Strong communication skills, including tailoring messages to technical and non-technical audiences, explaining complex concepts clearly and concisely, communicating progress and risks to non-technical stakeholders
  • Proven experience working effectively in a team-based environment

What the JD emphasized

  • Legal authorization to work in the U.S. is required.
  • We will not sponsor individuals for employment visas, now or in the future, for this job opening.