Biomedical Engineer

Job Summary

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