What You’ll Do 

• 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. 

What You’ll Need 

• 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 

Desired Characteristics 

• 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 

Preferred Qualifications 

• 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