Program Manager

 
Responsibilities
Responsible for specification, development, risk management, creation of traceability matrix, and overall lead of the medical device project through its entire life cycle
Manage complex schedules that involve both internal and external engineering teams, as well as vendors, while prioritizing activities for rapid execution of critical path work items
Manage identification and development of mitigations for critical project risks
Lead team meetings, design/technical reviews, meeting minutes, task management and follow up action items to closure
 
Education
BSc, MS in electrical engineering, computer science or biomedical engineering
 
Qualifications
8-10 years of experience developing medical devices
Solid understanding of design controls and risk management
Previous experience with ultrasound
Solid experience in preparing technical files for supporting regulatory submissions (including CE mark, US FDA)
Strong previous program management experience working with R&D electrical and software engineering teams
Understanding of all relevant standards to support medical device product development
Demonstrated ability to bring products from concept to market
Excellent written and verbal communication skills