Senior Manager, Lean R&D Processes
Job Description Summary
BD Medication Delivery Solutions (MDS) is seeking a highly hardworking and passionate Senior Manager, R&D Processes who serves as a key cross-functional partner to drive product and process efficiency objectives across the Medication Delivery Solutions (MDS) business unit. We value our hardworking employees, and whenever possible strive to help one of our associates grow expertly before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!
Our people make all the difference in our success.
BD is seeking an individual who has experience in developing and launching products in a compliant but efficient and effective manner using lean processes. This transformation has already begun, as the new Lean Design Control process has been rolled out to 850+ R&D associates, across 10+ global locations. This individual needs to be able to continue this journey and be comfortable driving cultural change through process behavior and be hands-on to ensure success.
- Establish, implement, improve, and maintain lean, compliant and modern, end-to-end R&D processes that empower teams and facilitate a streamlined user experience for teams developing different types of products around the globe.
- Inspire change management with regard to process behaviors and cultural change.
- Be responsible for the MDS design control process and support internal and 3rd party audits. Continuously improve the process to align with a multifaceted regulatory environment.
- Be responsible for the team of MDS SMEs in the assessment and development of Design Control standard methodologies
- Deliver up to date design control training to MDS associates. Conduct train-the-trainer sessions as needed.
- Develop and guide associate shift in demeanor by engaging, collaborating and mentoring associates in the development of their product development results.
- Supervise the health and efficiency of design control process by establishing and analyzing metrics and data that drive standard methodologies
- Support configuration and upgrades to current R&D tools and technologies.
- Establish and maintain strong collaborative partnership with other BD R&D organizations and external partners, as appropriate, in order to demonstrate best-in-class technologies, solutions, methods and capabilities.
- Develop realistic and relevant 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 and standard methodologies. Actively lead, mentor and empower team members and less-experienced associates, while also ensuring effective cross-functional communication and engagement.
- Empower team to lead continuous improvement projects for local platforms that impact all of MDS.
- Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures
- Optimally communicate program status to senior management.
PROFESSIONAL EXPERIENCE AND QUALIFICATIONS
The successful candidate will have a consistent record of product development and leadership in the medical device industry with a minimum of ten years of experience. Position can be based out of North Jersey, Salt Lake City or Southern California.
The candidate must have solid R&D experience developing and employing modern, lean product development methodologies and cross-functional work processes across large multi-disciplinary teams. Experience in data analytics and visualization is a plus.
The candidate will have the ability to build positive relationships and rapport with peers, subordinates, and superiors, in particular within the Quality, Operations and Regulatory functions. The candidate will have earned an undergraduate degree, preferably in engineering. An advanced degree will be advantageous.
REQUIRED KNOWLEDGE, SKILLS AND ATTRIBUTES:
- Authoritative knowledge and practical experience in the use of Medical Device Design Control regulations (CFR 820.30, ISO 13485:2016 / EU MDR; etc;) and standard methodologies
- Deep experience with streamlined and customer-centric implementation of Medical Device Design and Development standard methodologies 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
- Demonstrated ability to build cross functional relationships
- Exceptional written and oral communication skills required. Experience leading global teams is a strong plus
- Consistent track record of use of Lean Engineering principles and practices
- Strong background in organizational organisational change
- Experience in establishing metrics and their visual representation
- Ability to prioritize and deadlines
- Ability to adapt to changing priorities
- Action oriented with a focus on results
- Proven positive work ethic with a strong dedication to achieving project goals
- BS degree in Engineering subject area, Master preferred
- 10+ years of Engineering experience and Project Management expertise
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer! We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status!
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA CA – Brea, USA CA - San Diego TC Bldg C&D, USA UT - Salt Lake City, USA UT - Sandy
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"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