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)
Master’s or PhD is a plus
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
Prior software or medical device industry experience is preferred, but not required
Benefits
medical
dental
vision
paid time off
401(k) plan with employee and company contribution opportunities