Senior Project Manager at Health Services Company in Minneapolis, Minnesota, United States — $100K-$125K
- Health Services Company
- Minneapolis, Minnesota, United States USA
- 1/13/21 2021-01-13
Job ID: 20201230
Leading the project team through delivery milestones by working with key stakeholders as well as doing hands on work to complete documentation deliverables for the Quality Management System (QMS)
Delivering the product through launch, including planning and tracking, building relationships with key functional partners, ensuring delivery of our quality system deliverables, and reporting status to management.
Leading cross-functional teams for new product development as well as other high priority programs.
Ensuring project teams achieve commercialization objectives, coordinates collaborations with partners/evaluators, facilitates communications, and develop, drive and maintain schedules for project deliverables. Works closely with Development, Operations, Quality, Marketing, Regulatory, Medical Affairs and other departments to ensure project priorities and decisions are consistent between teams and corporate strategic plans.
Activities include communicating project status and critical path items to Sr. Management, developing and implementing timeline plans for product availability, monitoring project resources, convening periodic meetings, issuing meeting agendas and minutes, monitoring team performance goals, and assisting in resolution of problems/critical issues.
Working with colleagues in Quality and Regulatory to ensure the processes we use meet all quality and regulatory requirements, but also are lean and efficient for our diagnostics business.
Develop and leverage continual learning for best practices for project management and communication of key program metrics.
Strong knowledge of project management processes
Working knowledge of FDA regulations including 510k and PMA submission requirements
5-7 years’ experience as a project manager in medical device product development either for FDA
submission and/or CLIA/CAP laboratories.