Senior Biomedical Engineer - Remote Device Regulator

International Consulting Associates, Inc; Arlington (VA); Remote; USD 150,000 - 210,000; 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 (Vacation, Sick Leave, H

Education and Professional Development

Remote work from anywhere within the大陆

Job summary

ICA, Inc. is seeking a senior Biomedical Engineer to join a fast-growing team focused on evaluating and regulating medical devices. You will serve as a technical lead across the full product life cycle, interpreting regulatory requirements and guiding cross-functional teams to compliant outcomes.

The role emphasizes strong analytical skills, attention to detail, and clear communication with stakeholders. Remote work from EST with potential DMV-area consideration.

Qualifications

• Bachelor's degree in Biomedical Engineering with 8+ years of medical device experience.
• Experience in regulatory review processes (510(k), De Novo, PMA, IDE).
• Knowledge of FDA regulations and risk/quality standards.
• Ability to lead projects and manage multiple priorities.
• Excellent written and verbal communication; brief technical audiences.
• Ability to obtain Public Trust clearance.

Responsibilities

• Serve as technical lead on cross-functional teams through product life cycle.
• Analyze medical device submissions (510(k), De Novo, PMA, IDE).
• Evaluate issues and communicate findings to stakeholders.
• Develop SOPs, review protocols, and standards improvements.
• Mentor junior engineers and analysts.
• Ensure thorough documentation and SOP adherence.

Skills

Biomedical Engineering

Regulatory Affairs

Leadership

Communication

Education

Bachelor's in Biomedical Engineering

Master's in Biomedical Engineering

PhD in Biomedical Engineering

Job description

ICA, Inc. is seeking a senior Biomedical Engineer to join a fast-growing team focused on evaluating and regulating medical devices. You will serve as a technical lead across the full product life cycle, interpreting regulatory requirements and guiding cross-functional teams to compliant outcomes.

The role emphasizes strong analytical skills, attention to detail, and clear communication with stakeholders. Remote work from EST with potential DMV-area consideration.