Medical Device Project Manager

Description:
Lead Project Management activities in conjunction with a Core Technical Leader for projects from concept to CE/FDA filing, and commercialization.
Responsibilities:
Focal point for the company’s strategic partners
Coordinate tasks and resources across all functions including Technical team, Subcontractors, Quality, Regulatory Affairs, and Operations.
Responsible for compliance to medical device design control Design History File (DHF) and product development process for all aspects of the program.
Develop, track and report on program plan, detailed project schedule, critical path analysis, DHF project and product risks, change control requests, and program deliverables.
Communicate program status to management and cross functional teams.
Position Requirements:
Bachelor/ Master’s Degree in Mechanical Engineering or biomedical engineering.
5 years of relevant work experience in a multidisciplinary medical device company
Knowledge and experience in fine mechanics
Demonstrated successful management of project development – Mandatory
Knowledge of the product development process and phase gate Design Control process is required.
Knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.)
Sub-contractor management experience
Qualification:
• Strong communication and leadership skills
• Hand on experience with project planning and estimations processes
• Fluent in English – spoken as well as written