R&D Project Manager (34657)
Summary
Manages R&D projects for medical device development, coordinating cross-functional teams from concept to market release while ensuring compliance with FDA GMP regulations.
Job Summary
The Project Manager will take-on intensive, mission critical project management for the R&D Department team. These efforts will directly contribute to delivering innovative medical devices to surgeons, hospitals, and their patients. This includes leading and directing a cross-functional new product development team, coordination of all project related activities from concept to sales-release and resolving any project road blocks or obstacles to the successful release of the new product. Strong leadership skills are essential to be successful in this position.
Essential Functions, Duties, and Responsibilities
- Lead cross-functional resources assigned to new R&D product development projects
- Communicate project status and coordinate all project activities
- Strong organization skills to create Design History Files (DHF) for project assignments
- Maintain timelines, action item lists, and all necessary documentation for design control per FDA GMP's section 820 for medical devices and internal procedures
- Work closely with marketing, engineering, and operational departments to keep critical projects on schedule
- Plan and facilitate product development projects, normally consisting of multiple low-complexity projects and one major project
- Schedule teams work to meet completion dates and technical specifications
- Review and evaluate results of project activities
- Recommend changes in methods, design, or equipment where necessary
- Maintain project design history files in accordance with regulatory requirement
- Performs other related duties as assigned or requested
- Identify critical path project activities and mitigate project schedule risks