Biomedical Engineer (Remote, Continental United States)

ICA.ai; Arlington (VA); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Health Spending Account

Flexible Spending Account

Life and Disability Insurance

401(k) plan with company match

Paid Time Off

Education and Professional Development

Remote work from anywhere within the U

Job summary

ICA.ai is seeking a senior Biomedical Engineer to lead regulatory review activities for medical device submissions, translate complex requirements into clear, testable product needs, and ensure compliance across the total product life cycle.

You will collaborate with cross-functional teams, mentors junior staff, and contribute to FDA-focused review processes, quality assurance, and risk assessment while upholding stringent documentation standards.

Qualifications

• Bachelor's degree in Biomedical Engineering or related field with 8+ years of medical device experience; or Master's with 6+ years; or PhD with 3+ years.
• Experience in medical device regulatory review, regulatory affairs, quality assurance, clinical review, or 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.

Responsibilities

• Serve as a technical lead and device subject matter resource on cross-functional teams throughout the medical device total product life cycle, from pre-market 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

Skills

Regulatory review

FDA regulations

Project leadership

Data analysis

Written & verbal communication

Risk assessment

Education

Bachelor's in Biomedical Engineering

Master's degree

PhD

Job description

About ICA, Inc.

ICA.ai is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist government clients with evaluating and achieving their objectives. We have become a trusted advisor helping our clients by offering cutting‑edge innovation and solutions to complex projects. Our small company has grown significantly, and we're overjoyed at the opportunity to expand yet again!

We are results-focused and have a proven track record supporting federal agencies and large government services primes in three main areas: Public Health Research, Advanced Data Science, and Strategic Services. We support multiple federal health agencies, including FDA and CMS.

At ICA, we believe our success starts with our people. We foster a collaborative "one team" environment where work‑life balance is prioritized. We're building dynamic, highly skilled teams in a welcoming and supportive atmosphere. If you're passionate about using your expertise to make a difference, we want to talk to you.

We are looking for a 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 pre‑market 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 & TELEWORK

This is a remote position following Eastern Standard Time (EST). Candidates residing in the DMV area preferred.

ADDITIONAL INFORMATION:

ICA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity or expression, national origin, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.