Senior Clinical Engineer - Theranostic Neuro

Job Description Summary

Job Description

WhatYou’llDo

Drive the clinical development of imaging products, drug products, diagnostics, and Software as a Medical Device (SaMD) bydeterminingsafety, effectiveness, and clinical value.

Translate clinical and customer needs into functional requirements, contribute to software prototyping, supportverificationand 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

Productroadmappingand lifecycle planning

Develop andmaintainin-depth technical and clinicalexpertisewithin your domain through scientific literature review, customer interviews, conference attendance, and clinical site visits.

Applystrongunderstanding 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.

WhatYou’llNeed

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 anddemonstratedability 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 notrequired

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