This profile will require the candidate identified to work as Project Manager in New Product Development in a Medical Device company. The candidate MUST have Project Management experience. The candidate should also be experienced in medical product development.
Responsibilities:
•Manage Medical Device New Product Development project
•Be responsible for adherence to timelines and business commitment and ensure milestones are achieved
•Manage project risks and develop contingency plans when needed
•Capture project specific metrics and present progress reports to Program Management & other stakeholders
•Monitor overall progress of the project(s) and use of resources, budget & infrastructure as appropriate
•Report issues to the Customer and Client management to ensure appropriate closure
•Manage design History File, Design Control Plan
•Manage Design Verification and Validation activities
•Manage Risk Management activities
•Interact with all functional groups involved in product development process – Manufacturing, Design Quality, Marketing, External Supplier etc.
Qualifications:
Bachelor’s Degree in Mechanical Engineering, Bachelor’s Degree in Bio-Medical Engineering. Bachelor of Science with relevant experience will be acceptable
•At least 3 years relevant experience in Project Management, preferably in Medical Devices / Pharma industries.
•Knowledge of using Project Management and Program Management tools and concepts
•PMP or equivalent certification is preferable
•Strong knowledge of New Product Development, preferably in Medical Devices
•Medical device risk assessment techniques, design failure mode effect analysis (DFMEA)
•Exposure to Product Development Documentation
•Some exposure to Design Quality
•Orthopaedic or Spine Product knowledge will be an advantage
•Proficient with MS Office applications such as MS Word, PowerPoint, Excel and MS Project.
•Candidate should possess strong communication and inter-personal skills.
•Conflict management skills and the ability to manage complex cross-functional and cross-cultural teams is a must.
Crown Point, Indiana