Electrical Engineer / Regulatory Scientific Reviewer (Radiological Health) The Electrical Engineer / Regulatory Scientific Reviewer provides scientific, engineering, and regulatory review support for medical devices used in radiation therapy and related radiological health applications within FDA's Center for Devices and Radiological Health (CDRH). The reviewer evaluates the safety, effectiveness, performance, and technological characteristics of complex radiation-emitting medical devices throughout the product lifecycle and supports evidence-based regulatory decision making.
Key Responsibilities:- Review premarket and post market data for radiation therapy and other radiation-emitting medical devices, including linear accelerators, treatment planning systems, image-guided radiation therapy systems, brachytherapy devices, and related technologies
- Evaluate electrical, mechanical, software, and systems engineering aspects of medical devices to assess safety, effectiveness, and regulatory compliance
- Analyze device performance, failure modes, adverse events, recalls, and emerging safety signals
- Conduct technical assessments of design controls, risk management documentation, verification and validation testing, and cybersecurity considerations
- Prepare scientific reviews, technical memoranda, and regulatory recommendations supporting FDA decisions
- Collaborate with multidisciplinary teams of physicians, physicists, engineers, statisticians, and regulatory scientists
- Communicate complex technical findings to internal stakeholders and external partners
Minimum Qualifications:- Bachelor's degree or higher in Electrical Engineering from an ABET-accredited institution
- At least 10 years of professional experience
- Experience with radiation therapy systems, medical imaging equipment, radiation-emitting products, or related healthcare technologiesKnowledge of medical device design, testing, safety standards, and healthcare technology applications
Preferred Qualifications:
Experience with radiation oncology technologies, including linear accelerators, treatment planning systems, imaging systems, and radiation dose delivery technologiesKnowledge of medical device regulations, quality systems, risk management principles, and post market surveillance Strong analytical, technical writing, and communication skills Experience working with clinical, engineering, or regulatory teams in the medical device industry, healthcare systems, academia, or Federal Government This position supports CDRH's mission to protect and promote public health by ensuring the safety and effectiveness of radiation therapy technologies used in the diagnosis and treatment of patients. Must be US Citizen or Full Green Card holder. Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
