Biomedical Engineer
virtual vocationsDenver (CO)
About the role
Seeking a full-time remote Biomedical Engineer, the candidate will serve as a technical lead on cross-functional teams, analyzing medical device submissions and ensuring compliance with regulatory standards while driving innovation and patient safety throughout the product life cycle.
Key Responsibilities:
Serve as a technical lead and subject matter expert on medical device review processes, from premarket to postmarket
Analyze and evaluate medical device submissions and address issues raised during the review process
Develop and refine standard operating procedures (SOPs) and risk analysis protocols for device review
Required Qualifications:
Bachelor's degree in Biomedical Engineering or related field with 8+ years of experience; or a Master's with 6+ years; or a PhD with 3+ years
Demonstrated experience in medical device regulatory review and knowledge of FDA regulations
Experience analyzing clinical or performance datasets relevant to medical devices
Proven ability to manage projects and deliver high-quality work under pressure
Ability to obtain and maintain a Public Trust clearance
Before you apply
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Your profile is current
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Two examples you can talk through
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A number in mind
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Your notice period
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Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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