Biomedical Engineer (Remote, Continental United States)

ICA.ai•Arlington, VA

1d•Remote

About The Position

ICA.ai is seeking a Biomedical Engineer to join their growing team. This role is for a seasoned problem-solver who applies engineering and scientific expertise to the evaluation and regulation of medical devices. The ideal candidate is mission-driven, with a passion for advancing medical device innovation and patient safety across the total product life cycle. They will bring creative, scientifically rigorous thinking and 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.

Requirements

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

Nice To Haves

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)
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

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