virtual vocationsDenver, CO
Biomedical Engineer
Biomedical Engineer
Biomedical Engineer
virtual vocationsDenver, CO
yesterday
Surgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument Manufacturing
Apply for this 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
Also on the board Same function, level within a rung
Level
Manager
Location
Denver, CO
Occupation
Bioengineers and Biomedical Engineers
Industry
Surgical Appliance and Supplies Manufacturing
Posted
yesterday