Senior Biomedical Engineer, Regulatory Reviews (Remote)
ICA, Inc.
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Benefits offered by this job
Job summary
ICA, Inc. is seeking a Senior Biomedical Engineer to support medical device evaluation and regulation for federal health agencies. You'll serve as the voice of the device reviewer, translating complex needs into clear, testable requirements.
In this role, you will lead technical reviews, develop submission protocols and risk standards, mentor junior engineers, and present findings to senior stakeholders. Remote work from anywhere in the continental US is supported with competitive benefits.
Qualifications
- Bachelor's degree in Biomedical Engineering with 8+ years of experience; advanced degrees reduce years required.
- Working knowledge of FDA regulations, premarket pathways, and quality/risk standards.
- Ability to obtain a Public Trust clearance and excel in a remote environment.
- Competitive salary with 100% employer-paid medical, dental, and vision insurance.
- 401(k) match, PTO, education assistance, and remote work from anywhere in the continental US.
Responsibilities
- Lead technical reviews, analyze submissions, and assess device safety and effectiveness.
- Develop review protocols, risk standards, and maintain device submission repositories.
- Mentor junior engineers and present findings to senior stakeholders.
Skills
Education
Job description
ICA, Inc. is seeking a Senior Biomedical Engineer to support medical device evaluation and regulation for federal health agencies. You'll serve as the voice of the device reviewer, translating complex needs into clear, testable requirements.
In this role, you will lead technical reviews, develop submission protocols and risk standards, mentor junior engineers, and present findings to senior stakeholders. Remote work from anywhere in the continental US is supported with competitive benefits.
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