BD (Becton, Dickinson and Company) Staff Engineer, R&D Lean Processes in Franklin Lakes, New Jersey
Job Description SummaryBD is rapidly progressing with the integration with Bard in late 2017. As part of the ongoing integration with CareFusion and 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 business 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 continuously create value within the R&D function and our product portfolio by focusing on lean principles. We will liberate resources for investment by reducing costs of current products; streamlining policies, processes, and procedures; creating or modernizing tools; and appropriately planning and managing our global R&D footprint.
Reporting to the Sr. Manager, R&D Lean Processes, the Staff Engineer, R&D Lean Processes will work across legacy BD and Bard and will partner with business groups in redesigning and rolling out key R&D processes including Design Control procedures and processes. The incumbent 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.
BD Medication Delivery Solutions (MDS) is seeking a highly talented and passionate Staff Engineer, R&D Lean Processes who serves as a key cross-functional integrator to drive product and process efficiency objectives across the $3.8 Billion Medication Delivery Solutions (MDS) business unit. We value our talented employees, and whenever possible strive to help one of our associates grow professionally 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. They need to be comfortable driving cultural change through process behavior. They need to be hands-on to ensure success.
Implement modern, end-to-end processes that empower teams and facilitate a streamlined user experience for R&D teams developing different types of products around the globe
Provide leadership and influence across functions such as QA, RA, Ops, Med Affairs to ensure specific process metrics are met.
Develop compliant but lean R&D processes and procedures beginning with Design Control and Risk Management.
Execute change management via training with regard to process behaviors and cultural change. Guide associate shift in mindset by engaging, partnering and collaborating in the development of their deliverables.
Participate in Design Reviews to ensure design and process robustness and compliance.
Establish and maintain strong knowledge of processes and regulatory developments with other BD R&D organizations and external partners, as appropriate, in order to leverage best-in-class technologies, solutions, methods and capabilities.
Execute 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 best practices. Actively lead, mentor and motivate team members and less-experienced associates, while also ensuring effective cross-functional communication and engagement.
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.
PROFESSIONAL EXPERIENCE AND QUALIFICATIONS
The successful candidate will have a proven record of product development in the medical device industry with a minimum of eight years of experience.
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.
The candidate will have the ability to build strong partnerships and rapport with peers, subordinates, and superiors, in particular within the Quality and 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:
Deep 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
Practical 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 build cross functional relationships
Exceptional written 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
Action oriented with a focus on results
Demonstrated positive work ethic with a strong commitment to achieving project goals
An Undergraduate degree in an engineering field is required; an MBA is desirable.
BS degree in Engineering discipline, MS/MBA preferred
8+ years of Engineering experience in Medical Devices or regulated industry
Primary Work LocationUSA NJ - Franklin Lakes
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