Biomedical Engineer to join our growing team!
ABOUT THE ROLE:As a senior
biomedical engineer, you are a seasoned problem-solver who applies engineering and scientific expertise to the evaluation and regulation of medical devices. You are mission driven, with a passion for advancing medical device innovation and patient safety across the total product life cycle. You bring creative, scientifically rigorous thinking, and you serve as the voice of the medical-device reviewer, translating complex review needs into clear, testable requirements and validating that delivered capabilities work the way reviewers actually work.
KEY RESPONSIBILITIES- Serve as a technical lead and device subject matter resource on cross-functional teams throughout the medical device total product life cycle, from premarket review through postmarket surveillance
- Analyze medical device submissions and records (e.g., 510(k), De Novo, PMA, IDE, and postmarket submissions)
- Evaluate issues raised by subject matter experts across disciplines during device review, assess their significance to the device's safety, effectiveness, and benefit-risk determination, and analyze how those issues are conveyed to stakeholders and resolved
- Identify patterns, gaps, and opportunities for improvement across device types, regulatory pathways, and review divisions
- Build and maintain a repository of representative device submissions and review precedents to support reviewer needs and requirements definition
- Define meaningful alert categories, priorities, reviewer actions, and escalation paths
- Evaluate alert relevance, false positives, false negatives, evidence quality, usability, and reviewer effort
- Develop and refine SOPs, RWE review protocols, and RWE standards for device review, and recommend improvements grounded in analytic findings and current FDA guidance
- Lead and support device risk analysis activities, including hazard identification, risk estimation, and benefit-risk assessment
- Author and present research findings, technical reports, and recommendations to senior stakeholders and leadership
- Mentor and provide technical guidance to junior engineers and analysts, including review of their work products
- Ensure adherence to SOPs and maintain thorough documentation of all review work
REQUIRED QUALIFICATIONS:- Bachelor's degree in Biomedical Engineering or a similar discipline with 8+ years of relevant medical device experience; or a Master's degree with 6+ years; or a PhD with 3+ years
- Demonstrated experience in medical device regulatory review, regulatory affairs, quality assurance, clinical review, or a related regulated field
- Working knowledge of FDA medical device regulations, premarket pathways (510(k), De Novo, PMA, IDE), and applicable FDA guidance
- Working knowledge of device quality and risk standards
- Experience analyzing complex clinical or performance datasets and evaluating study design and data quality for device evidence
- Proven ability to lead projects, manage competing priorities under pressure, and deliver high-quality work with minimal oversight
- Exceptional attention to detail and organizational skills
- Excellent written and verbal communication skills, including the ability to brief technical and non-technical audiences
- Ability to obtain and maintain a Public Trust clearance
PREFERRED QUALIFICATIONS:- Familiarity with common device review topics
- Familiarity with postmarket and real-world data sources for devices (e.g., MAUDE, device registries, UDI data) and real-world evidence in device submissions
- Experience supporting FDA (particularly CDRH) or other HHS agencies
- Experience on federal government contracts
- Prior successful experience working in a remote environment
- Experience developing SOPs, standards, or review protocols
- Prior experience mentoring or leading small teams
- Advanced degree or relevant certifications (e.g., RAC, CQE)
STRONGLY PREFERRED QUALIFICATIONS:- Previous experience as a medical-device reviewer, with experience in medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or a related regulated-document field
- Strong understanding of medical-device submission documentation and review processes
- Experience gathering requirements and working directly with clients, reviewers, or other domain stakeholders
- Ability to translate complex domain needs into clear, testable product requirements
- Strong analytical, facilitation, documentation, and communication skills
- Software and technology knowledge is not required or expected
UNAUTHORIZED USE OF AI ASSISTIVE TECHNOLOGY: All application materials must be your own original work, and interviews must be completed independently. The use of AI-generated content or AI-assisted technologies during the application or interview process is prohibited unless interviewers provide explicit permission for specific activities during a live technical assessment. Any unauthorized use of AI will result in disqualification from the hiring process.
BENEFITS: We invest in our team members so you can live your best life professionally and personally, offering a competitive salary and benefits.
- Health Insurance -100% employer-paid premiums - ICA covers the full cost of one of three offered medical plans
- Dental Insurance
- Vision insurance
- Health Spending Account
- Flexible Spending Account
- Life and Disability insurance
- 401(k) plan with company match
- Paid Time Off (Vacation, Sick Leave and Holidays)
- Education and Professional Development Assistance
- Remote work from anywhere within the continental United States
LOCATION & TELEWORKThis is a remote position following Eastern Standard Time (EST). Candidates residing in the DMV area preferred.
