Global Process Owner, Design Control
Job Description SummaryBD is rapidly progressing on its transformational journey. As part of the ongoing integration in an effort to accelerate R&D productivity and efficiency, we intend to modernize and streamline our core product development processes and capabilities. This transformation is vital to supporting our now-expanded existing businesses and delivering the innovation and new products that our customers and stakeholders are counting on.
As such, a critical need has emerged to redouble our efforts to continuously create value in our product portfolio by focusing on lean principles. We will liberate resources for investment, streamlining policies, processes, and procedures; creating or modernizing tools; and appropriately planning and managing our global R&D footprint.
Reporting to the Director, MDS R&D Lean Engineering, the Global Process Owner, Design Control will work across BD Segments, Global Regions and Functions to lead a team in revamping key Design Control processes and procedures. The leader will work closely with Quality and other cross-functional management to lean out and successfully implement R&D processes in order to deliver products to marketing with more predictability and speed.
In accordance with all applicable federal, state and local laws/regulations and Corporate BD, procedures and guidelines, this person in this position:
- Design, develop, and implement modern, end-to-end R&D processes that empower and facilitate a streamlined user experience for teams developing different types of products around the globe
- Drive change management with regard to process behaviors and cultural change.
- Develop and guide associate shift in mindset by engaging and collaborating in the development of their deliverables.
- Establish and maintain strong collaborative partnership with other BD R&D organizations and external partners, as appropriate, in order to leverage best-in-class technologies, solutions, methods and capabilities.
- Develop realistic and actionable process design and implementation plans; demonstrate strong accountability for successful completion of programs with successful user uptake.
- Proactively develop, maintain and share knowledge in specialized area(s), remaining up-to-date on current trends, internal and external audit observations and best practices.
- Actively lead, mentor and motivate and train team members and less-experienced associates, while also ensuring effective cross-functional communication and engagement.
- Establish and manage Collaborative Community for Design Control and Product Development best practices. Define metrics and measures for the Design Control and Product Development
- Support evaluation and assessment of new technologies / IT solutions, processes and industry trends that can or have the potential to impact our business strategies. Partner with IT teams to implement solutions across BD.
- Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures
- Effectively communicate program status to senior management.
Supervision and Budgetary Responsibility:
- Manages project budgets and IT budgets as needed.
- Leads collaborative community (cross business/cross functional network of SMEs) which will support and drive change for Design Control
Education and Experience:
- Expert knowledge and practical experience in the use of Medical Device Design Control regulations (CFR 820.30, ISO 13485:2016 / EU MDR; etc;) and best practices
- Deep experience with streamlined and customer-centric implementation of Medical Device Design and Development best practices and Verification & Validation (V&V)
- Experience in facilitating groups to analyze, characterize and optimize processes
- Demonstrated ability to lead change, to listen, influence, align strategy and drive execution across organizational boundaries, including various levels of the organization (executive, peers, working teams) and across multiple functions
- Exceptional technical writing and oral communication skills required. Experience leading global teams is a strong plus
- Strong track record of use of Lean Engineering principles and practices
- Ability to manage multiple priorities and deadlines
- Ability to adapt to changing priorities; Ability to develop creative approaches and solutions necessary to resolve complex problems.
- Action oriented with a focus on results
- Demonstrated positive work ethic with a strong commitment to achieving project goals
- Typically requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline. Graduate degree preferred.
- At least 15 years of experience in medical device product development / project management
- Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.
- Travel is required, given the global scope of the role, and would vary in intensity depending on the evolving business needs. Anticipated travel on a global basis to be around 20%.
Primary Work LocationUSA NJ - Franklin Lakes
Recommendto a friend
"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ