Senior Clinical Engineer – RO & GIP

About the role

You will help guide the clinical development of imaging products, diagnostics, and Software as a Medical Device (SaMD). You’ll play an important role in evaluating safety, effectiveness, and clinical value, while helping translate clinical and customer needs into product direction and innovation.

Responsibilities

• Support the clinical development of imaging products, diagnostics, and Software as a Medical Device by helping determine safety, effectiveness, and clinical value.
• Translate clinical and customer needs into functional requirements that inform product development.
• Contribute to software prototyping, support verification and validation (V&V) testing, and help drive iterative improvements following product launch.
• Lead and contribute to cross-functional initiatives that support product success, including work related to: Product roadmap execution and product lifecycle planning, Software as a Medical Device regulatory submissions (such as 510(k)), sponsored research agreements.
• Build and maintain technical and clinical expertise within your area through activities such as: reviewing scientific literature, conducting customer interviews, attending conferences, visiting clinical sites.
• Apply an understanding of business priorities to help execute strategy and deliver results that support broader organizational goals.
• Use judgment, prior experience, analytical thinking, and guidance from others to recommend practical solutions, including those that may extend beyond standard approaches.
• Collaborate closely with internal partners across engineering, regulatory, quality, and marketing, as well as with external clinical professionals.
• Contribute as a strong individual team member and, where applicable, provide informal mentorship, guidance, and knowledge-sharing to more junior colleagues.

Requirements

• Bachelor’s degree from an accredited college or university in a relevant field such as: Biomedical Engineering Radiologic Technology or Radiologic Sciences Computer Science Medical Physics Or a related discipline
• 5+ years of molecular imaging Software as a Medical Device experience OR 7+ years of closely related adjacent experience
• Strong problem-solving and analytical skills
• Ability to communicate and collaborate effectively with: Clinical professionals Engineering, regulatory, quality, and other cross-functional internal teams
• Demonstrated ability and aptitude to build clinical, anatomical, and technical domain knowledge
• Willingness to travel periodically for medical conferences, customer meetings, and site visits

Qualifications

• Bachelor’s degree from an accredited college or university in a relevant field such as: Biomedical Engineering Radiologic Technology or Radiologic Sciences Computer Science Medical Physics Or a related discipline
• Master’s degree or PhD in a relevant field
• Prior experience in the software or medical device industry; strong familiarity with design controls and regulatory submissions
• Direct experience with imaging software
• Strong technical writing skills
• Strong communication skills, including the ability to: tailor messages for both technical and non-technical audiences, explain complex concepts clearly and concisely, communicate progress and risks effectively to non-technical stakeholders
• Experience working successfully in team-based environments
• Project management skills, including planning, documentation, and execution
• Experience mentoring junior engineers, delegating appropriately, and supporting team growth
• Recognized depth of expertise in advanced molecular imaging software

Preferred Qualifications

• Master’s degree or PhD in a relevant field
• Prior experience in the software or medical device industry; strong familiarity with design controls and regulatory submissions
• Direct experience with imaging software
• Strong technical writing skills
• Strong communication skills, including the ability to: tailor messages for both technical and non-technical audiences, explain complex concepts clearly and concisely, communicate progress and risks effectively to non-technical stakeholders
• Experience working successfully in team-based environments
• Project management skills, including planning, documentation, and execution
• Experience mentoring junior engineers, delegating appropriately, and supporting team growth
• Recognized depth of expertise in advanced molecular imaging software

Benefits

• Competitive benefits package including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
• Relocation assistance provided.

Pay

The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI).

Schedule

Not specified.

Skills

• Proactive, growth-oriented mindset
• Curiosity and a thoughtful approach to investigating complex problems
• The ability to analyze challenges and develop effective solutions
• Strong written, verbal, and technical communication skills
• A collaborative working style and commitment to shared outcomes
• Interest in continuous learning and deepening your clinical and technical expertise

Benefits

• Competitive benefits package including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
• Relocation assistance provided.