Bachelor's degree in Electrical Engineering from an ABET-accredited institution
10+ years of professional experience
Experience with radiation therapy systems or medical imaging equipment
Knowledge of medical device design and safety standards
Familiarity with healthcare technology applications
Responsibilities
Review premarket and post-market data for radiation-emitting medical devices
Evaluate engineering aspects to assess safety and regulatory compliance
Analyze device performance and emerging safety signals
Conduct technical assessments of design controls and risk management
Prepare scientific reviews and regulatory recommendations
Collaborate with multidisciplinary teams
Communicate complex technical findings to stakeholders
Benefits
100% telework flexibility
Monday-Friday schedule, excluding holidays
Opportunity to work on impactful healthcare technologies
Engagement with a multidisciplinary team
Support for public health initiatives
Full Job Description
Position Title: Electrical Engineer / Regulatory Scientific Reviewer (Radiological Health)
Employment Type: Full-time Employee
Schedule: Monday-Friday, excluding holidays
Location: 100% Telework
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
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 technologies
Knowledge 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 technologies
Knowledge 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.
