The successful candidate will contribute to ongoing R&D projects providing regulatory guidance and monitoring compliance, in addition to generating and presenting monthly milestone update reports to funding sources. This position is a full time 40 hour a week, in-person job that reports directly to the Chief Scientific Officer.
We are seeking an experienced Biomedical Device R&D Technical Project Manager to lead and manage the development of cutting-edge medical devices. The ideal candidate will have a strong background in biomedical engineering, extensive experience in R&D project management, and a proven track record of successfully navigating at least two medical devices through FDA regulatory approval processes. This role requires a combination of technical expertise, strong technical communication skills with strategic planning, and leadership skills to help drive ongoing projects to market.
Responsibilities
Determine and develop user requirements for biomedical systems under development, and provide regulatory guidance to ensure maximum usability and successful FDA submission.
Provide regular developmental milestone reports that include illustrations of acquired data and analyzed results.
Qualifications
Bio/Biomedical Engineering or equivalent degree, Biomedical device regulatory certification and/or substantiative work experience. Excellent verbal and written communication skills, and great people skills.