Senior Project Manager, R&D Cary, Illinois
Title: Senior Project Manager, R&D – Design Controls Process
Job Type: Full-Time
Primary Location: Portage, MI or Cary, IL (Hybrid)
Vignetic is looking for a Senior Project Manager who will provide leadership and direction to ensure a best-in-class Design Control system and methods that will be employed across all Medical R&D sites. In this role, you will be known as the division subject matter expert and leader to define, develop, and implement effective and efficient processes and supporting tools globally across the division.
Roles & Responsibilities:
- Partner and influence all Medical division R&D site process owners (SPO) to the design control strategy. Drive collaboration with program team members, resolve conflicts, and maintain a cohesive community.
- As a divisional process owner (DPO), be accountable to maintain and drive continuous improvements in design controls to show improved efficiency, compliance, and competency.
- Influence and collaborate with Corporate Process Owner (CPO) on Design Control and Medical QMS plans, while delivering a compliant, efficient, and balanced design controls framework. Represent the division in ongoing corporate design controls harmonization tasks and plans.
- Represent Medical Division design control process during multiple agency audits.
- Work closely with subject matter experts in adjacent DPO/CPO work streams (Ex: Risk Management) for continuous improvements in design controls and to always ensure alignment.
- Champion the creation and implementation of simplified next generation design control process for all Medical R&D sites based upon deep understanding of current business practices, product risk classifications, and site capabilities.
- Communicate status of design control projects at Medical to Corporate Quality Office, including the CPO, as well as other R&D and Executive leadership.
- Ongoing assessment of Design Control procedures in use at all Medical R&D site. Establish key metrics across sites to accurately represent the state of design controls at each site.
- Bachelor’s degree in an engineering discipline required.
- 6+ years of relevant R&D, new product development. Quality System, and/or FDA design controls experience required.
- Experience in the medical device software development process and lifecycle.
- Demonstrated versatility and a willingness to influence and lead a team through change and ambiguity.
- Excellent interpersonal communication, collaborative teamwork, conflict management, and negotiation skills.
- Ability to build trusting relationships and influence at all working levels.
- Demonstrated ability to mentor, train, and develop team members.