Senior Clinical Engineer - Theranostic/ Neuro

GE HealthCare is a leading company in the medical imaging software industry, dedicated to providing innovative solutions for healthcare organizations. They are seeking a Senior Clinical Engineer to drive the clinical development of imaging products, ensuring safety, effectiveness, and clinical value while collaborating with cross-functional teams.

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
• 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
• Ability to communicate and collaborate effectively with 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
• 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
• Major contributor to 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
• Strong communication skills, including explaining complex concepts clearly and concisely
• Strong communication skills, including communicating progress and risks to non-technical stakeholders
• Proven experience working effectively in a team-based environment