R&D Program Manager, Divisional Design Controls (R451819)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
What you will do-
Provides leadership and direction to ensure Stryker Medical has a best in class Design Control system and methods that will be employed across all Medical R&D sites. The Division Process Owner (DPO) 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. The role will report into divisional R&D leadership and collaborate with the corresponding Corporate Process Owner (CPO) to continuously improve the medical design controls system. The DPO will lead, influence, and collaborate with site process owners and serve as their single point of contact for process related matters. The DPO is accountable for ensuring cross functional alignment and support to drive customer experiences and improvements holistically through the design control system.
Lead, influence and mentor 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 ensure alignment at all times.
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 throughout Stryker.
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.
What you need-
Bachelor’s degree in an engineering discipline required
8+ years of relevant R&D, Quality System, and FDA design controls experience required
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
Know someone at Stryker?
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