BD (Becton, Dickinson and Company) Sr. Director, Next-Generation Instrumentation in San Jose, California
Job Description Summary
The Sr. Director of Instrumentation Product Development provides R&D leadership, functional management, and coordination of all activities surrounding the development of BD Biosciences next-generation flow cytometry instrumentation platform (cell sorters and analyzers). The cross-functional R&D organization under the purview of this leader is comprised of a large team, spanning the engineering disciplines of hardware, software, firmware, and systems engineering, as well as reliability, verification, validation, and applications development. This person will guide the team through technology development, product development, manufacturing transfer, and sustaining post-launch activities, that are associated with the worldwide launch of BD’s next-generation instrumentation platform. Further, this leader will ensure that (1) world-class technical standards are maintained across all functions within the team, and (2) technical decisions made within the development effort are aligned with long-term priorities of the business and (3) the resulting product platform both meets customer needs and exceeds their expectations for both performance and quality.
The ideal candidate will have significant experience with New Product Introduction (NPI) of complex biomedical instrumentation (ideally flow cytometry) in the life sciences space. Candidates with comparable experience in adjacent spaces will also be considered. The candidate will need to work effectively with business stakeholders for this critical program, including leaders of the Portfolio Management Office, the commercial business functions, and the BD Biosciences Worldwide Leadership Team, up to and including executive-level leadership. This role reports directly to the Worldwide Vice President of R&D, participates as a member of the R&D Leadership Team, and will have an R&D function of more than 60 associates report to them.
As flow cytometry instrumentation development is a highly multi-disciplinary field, the successful candidate must have significant technical expertise in one or more of the following areas:
Additionally, a strong understanding of the life science instrumentation (or related) markets, product development in a regulated environment, as well as experience managing a large (>30 FTE’s) cross-functional R&D organization are must-have qualifications. Demonstrated ability both hiring and successfully managing top technical talent is also required.
The successful candidate for this position:
Sets the vision for a word class life sciences R&D team, and formulates strategic and tactical plans / roadmaps to implement this vision over a well-defined product development period.
Works closely with program managers and engineering team members to ensure proper resourcing and expertise is provided to each product development team.
Actively works to attract, recruit, retain and develop top talent to build a best in class capability.
As a member of the R&D Leadership team, Sr. Director of Instrumentation Product Development collaborates with other leaders to drive the overall strategic objectives of R&D and broader business.
Frequently interacts with other senior functional leaders, including Marketing, Program Management, Operations, Quality, Business Platforms, Medical, and Regulatory to ensure that the systems under development meet overall business needs.
Manages within budgetary boundaries defined by the fiscal year budget and quarterly forecasts.
Works on complex problems where analysis of data requires an in-depth evaluation of various factors.
Introduce and institutionalize value-added engineering practices into BD.
Models best in class R&D functional excellence.
Responsible for the stewardship of best practice R&D processes and methodologies, ensuring consistent application across all programs and the continuous improvement of the processes including:
Design Technical Management & Reviews
System Defect Tracking
Integration & Test
Establish departmental tasks and priorities necessary to meet program objectives, including monitoringcost/schedule/staffing/performance to plan.
Participates in Design and Technical Reviews to ensure customers’ needs are satisfied and designs are consistent with systems-level requirement.
Education and Experience:
Minimum of a MS degree in Electrical Engineering, Engineering Science, Hardware Engineering, Software Engineering or a related field. Ph.D. preferred.
Prior direct experience in design and development of complex instrumentation and systems in the life sciences industry or related field.
Minimum of 5 years' experience in a functional leadership role and/or leading a multidisciplinary R&D team. Experience in a start-up environment is considered a plus.
Minimum 5 years of product development experience in instrumentation for life sciences applications or related fields of similar regulatory complexity.
Education and/or experience in Immunology, Cell Biology or a related scientific discipline highly desirable.
Minimum of 3 years of relevant industry experience in a regulated environment.
Demonstrated team management and leadership skills for complex programs.
Knowledge and Skills:
Highly effective interpersonal, leadership and influencing skills are a requirement.
Has up to date engineering skills and product development knowledge, including knowledge of modern optical, electronic, computational, and fluidic technologies.
Ability to create, maintain and improve product development processes and documents including SOPs and desk procedures.
Ability to manage departmental budget, resources and their assignment to multiple programs.
Effective organization and planning skills.
Ability to work effectively with teams.
Demonstrated creative and innovative problem solving ability.
Has previous Design Control experience in a regulated environment.
Knowledge of Quality Systems Regulations, ISO guidelines, and Good Laboratory Practices.
Experience with system development lifecycles and requirements development for complex systems.
Has experience with tools for managing customer, system, and subsystem level requirements.
Experience with requirements development, design & testing.
Design for Six Sigma (DFSS) training and qualifications are a plus.
Primary Work LocationUSA CA - San Jose
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.