Sr. Program/Project Manager- Medical Devices

The Mom Project is excited to partner with our New Jersey based pharmaceutical client. We are currently looking for a contract Sr. Program/Project Manager.

This role is currently remote, but candidates must be able to commute to either Princeton, NJ or Hayward, CA one Covid restrictions are lifted.

The Senior Program/Project Manager will lead a cross functional team in the design and development activities for next generation wearable medical sensors. Working with internal and external resources, he/she will establish project schedule, coordinate activities, ensure that deliverables are ready, makes sure that development activities are compliant to internal SOP’s and external regulations. This senior position will play a lead role in ensuring the timely delivery of our new, innovative, wearable, wireless medical devices. He/she will work independently, as well as lead a matrixed team of internal and external resources.

The Role

• Coordinate all project activities, across all internal resources as well as external development partners


• Establish and maintain project schedule and monitor timely execution


• Shepherds the project from initial concept development, to smooth transfer to manufacturing


• Creates and manages delivery of product development documentation to support regulatory filings including: Technical Files for UL, CE and FDA (510(k), NDA applications. 


• Ensures compliance with all regulations that govern medical device design and manufacturing, including FDA, ISO and UL guidelines. 


• Participate in design reviews to ensure requirements and specifications are being met


• Participate in risk analysis activities


• Stay aware of industry trends via conferences and publications

Qualifications

• Minimum of 5 years' experience in Project Management and design transfer to manufacturing for high volume manufacturing


• Proficient with MS Project, Word, Excel, PowerPoint


• Previous experience with wearable sensors is a plus


• Proven ability to work with external partners/contractors


• Strong organization skills (self-managed)


• Excellent communication (verbal and oral) skills 


• Solid understanding of medical device design controls, standards, and regulations including ISO 13485, ISO 14971 and 21 CFR 820


• Demonstrated leadership skills in a matrixed environment


• Ability to work independently

Education and Experience

• BS (MS preferred) in an Engineering discipline or equivalent from an accredited college or university


• Minimum 5 years of experience in the medical device industry