GE HealthCare is a leading company in the medical technology sector, focused on providing vendor-neutral imaging software to enhance clinical workflows. The Senior Clinical Engineer will drive the development of imaging and diagnostic products, ensuring safety and effectiveness while collaborating with multidisciplinary teams to support product success.
Responsibilities:
- Drive the clinical development of imaging products, drug products, diagnostics, and Software as a Medical Device (SaMD) by determining safety, effectiveness, and clinical value
- 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
- 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
- Develop and maintain in-depth technical and clinical expertise within your domain through scientific literature review, customer interviews, conference attendance, and clinical site visits
- 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
- Exercise judgment to propose solutions beyond established parameters, using prior experience, analytical thinking, and guidance as needed
- Collaborate effectively with multidisciplinary internal teams (engineering, regulatory, quality, marketing) and external clinical professionals
- Act as a strong individual contributor with proven interpersonal skills, or as an early people leader providing informal mentorship, guidance, and knowledge-sharing to junior team members
Requirements:
- 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
- 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 and 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, and communicating progress and risks to non-technical stakeholders
- Proven experience working effectively in a team-based environment