Biomedical Engineer

This is a fully remote position, open to applicants in Virginia.

📋 Description

• Act as a technical leader and subject matter expert on cross-functional teams throughout the entire medical device product life cycle, from premarket evaluation to postmarket monitoring.

• Review and analyze medical device submissions and documentation, including 510(k), De Novo, PMA, IDE, and postmarket submissions.

• Assess issues identified by subject matter experts across various disciplines during device evaluations, determine their significance regarding device safety, effectiveness, and benefit-risk analysis, and evaluate how these issues are communicated to stakeholders and addressed.

• Recognize patterns, deficiencies, and opportunities for enhancement across different device types, regulatory pathways, and review divisions.

• Develop and uphold a repository of exemplary device submissions and review precedents to assist reviewer requirements and needs.

• Establish meaningful alert categories, priorities, reviewer actions, and escalation procedures.

• Assess the relevance of alerts, including false positives, false negatives, evidence quality, usability, and reviewer effort.

• Create and improve SOPs, RWE review protocols, and RWE standards for device evaluations, recommending enhancements based on analytical findings and current FDA guidelines.

• Lead and facilitate device risk analysis activities, which encompass hazard identification, risk estimation, and benefit-risk assessment.

• Author and present research findings, technical reports, and recommendations to senior stakeholders and leadership.

• Mentor and offer technical guidance to junior engineers and analysts, including reviewing their work products.

• Ensure compliance with SOPs and maintain comprehensive documentation of all review activities.

⛳️ Requirements

• A Bachelor's degree in Biomedical Engineering or a related discipline with 8+ years of relevant medical device experience; or a Master's degree with 6+ years; or a PhD with 3+ years.

• Proven experience in medical device regulatory review, regulatory affairs, quality assurance, clinical review, or a similar regulated field.

• Solid understanding of FDA medical device regulations, premarket pathways (510(k), De Novo, PMA, IDE), and applicable FDA guidelines.

• Familiarity with device quality and risk standards.

• Experience in analyzing complex clinical or performance datasets and assessing study design and data quality for device evidence.

• Demonstrated capability to lead projects, manage competing priorities under pressure, and produce high-quality work with minimal supervision.

• Exceptional attention to detail and strong organizational skills.

• Excellent written and verbal communication skills, including the ability to brief both technical and non-technical audiences.

• Ability to obtain and maintain a Public Trust clearance.

• Knowledge of 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 in supporting FDA (particularly CDRH) or other HHS agencies.

• Background in federal government contracts.

• Prior successful experience working in a remote setting.

• Experience in developing SOPs, standards, or review protocols.

• Previous experience mentoring or leading small teams.

• An advanced degree or relevant certifications (e.g., RAC, CQE).

• Prior experience as a medical-device reviewer, with experience in medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or a similar regulated-document field.

• Strong understanding of medical-device submission documentation and review processes.

• Experience gathering requirements and collaborating with clients, reviewers, or other domain stakeholders.

• Ability to convert complex domain requirements into clear, testable product specifications.

• Strong analytical, facilitation, documentation, and communication abilities.

• Software and technology knowledge is not required or expected.

• All application materials must be your own original work; the use of unauthorized AI-assisted technologies during the application or interview process is prohibited.

🏝️ 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.