BD (Becton, Dickinson and Company) Senior Manager, R&D (Advanced Drug Delivery Devices, Combination Products) in Franklin Lakes, New Jersey
Job Description Summary
BD is in search of a talented Senior RD Manager looking to take their previous development experiences with wearable infusion pumps, large volume injection devices, or the like to the next level.
As a Senior RD Manager with BD’s Pharmaceutical Systems, Self-Administration Injection Systems (SAIS) team in Franklin Lakes, NJ, you will be responsible for guiding a technical team toward the design, development, verification and validation of combination products in support of BD’s global R&D pipeline with special focus on the parenteral delivery of biologics and biosimilars. At its core, this role will give you the opportunity to develop user-centric drug delivery solutions designed to drive patient empowerment, independence, compliance, and improved health outcomes.
The Senior R&D Manager will perform as a “player-coach” by contributing to team goals as a hands-on technical leader and proponent of technical excellence in parallel with functional management of a diverse technical team.
What you get to do every day:
Functional management of a diverse technical team
Builds & nurtures a high performing and engaged team of R&D Engineers
Fosters a work environment that rewards risk taking, rapid learning, and a bias for action
Prioritizes his / her team’s performance & career development. Provides creative growth opportunities for high potential associates in alignment with business objectives. Provides timely and regular performance feedback to all associates
Identifies & develops technical training and development plans. Mentors or serves as a resource to share specialized knowledge with others. Maintain leadership and technical capabilities through continued education or training
Determines resource needs for new product development and existing product support and assigns personnel as appropriate
Ensures that department personnel have clearly defined tasks and annual goals which are aligned with broader functional and business objectives
Responsible for hiring, talent development and pipeline management within his / her team
Plans and organizes project deliverables according to project scope, timeline and resources
Shares and leverages extensive medical device product design and development knowledge and experience
Fostering & embedding engineering best practices
Delivers on new and exciting advanced drug delivery solutions as a technical leader on a cross-functional project team through all phases of the project lifecycle in accordance with business goals
Represents the organization as a prime technical contact for pharma partners on a B2B product development platform
Translates business requirements into a robust, scalable technical design
Pursues complex problems by applying sound engineering principles, utilizing experimental, computational and analytical methods to a range of technical product development challenges over a range of products from simple disposable components to complex mechanical device assemblies
Improves product development cycle and quality via the application of DFSS and Lean Product Development Tools
Mentors a team of R&D associates in best design practices, analysis, simulation and verification of subsystems and systems
Challenges and supports project teams by ensuring technical excellence through rigorous design and technical reviews. Acts as subject matter expert and independent reviewer in these reviews
Develops and guides technical design/methodologies to achieve product goals, and applies standard management techniques to achieve project goals
Assigns and deploys resources across the portfolio of projects in order to meet business objectives
Guides the conception and planning for product development projects of any size and complexity
Technical & Analytical Skills:
Expert knowledge in related technical fields
Able to draw upon technical breadth to evaluate concepts outside area(s) of personal expertise
Excellent analytical skills & discipline; able to conduct thorough analysis of concepts that have high uncertainty
Intellectual drive to gain firsthand understanding of customer needs
Focused on maintaining current knowledge in technical and scientific fields
Excellent critical thinking skills; able to constructively challenge ideas and invite critical feedback
Ability to set a vision and engage the diverse team to achieve that vision
Natural collaborator. Leads through building relationships; demonstrated facilitation skills across different functions; motivated by collective success
Agile learner, tolerant of risk, and biased towards action
Skilled communicator at all levels; able to translate complex technical concepts for non-expert audiences.
Work closely with functional and project managers to identify and mitigate technical issues to reduce programmatic risks
You will be effective if you have:
History of developing/launching medical product(s) through a phase gate development cycle in an ISO13485 environment (or equiv.)
A propensity to quickly learn new concepts and technologies and convert them into customer solutions
The initiative to identify opportunities and drive continuous improvement efforts
Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals, teams and customers
Experience in guiding team/individuals to develop technical solutions to complex problems
Education and Experience: Minimum of a M.S. in Mechanical Engineering, Engineering Science, Physics, Applied Physics or related discipline
Advanced business or management degree preferred but not required
Minimum of 10 years’ related work experience in medical device development with an emphasis on mechanical engineering and fluid mechanics
Proven track record of executing complex system designs incorporating mechanical subsystems, preferably in the medical device field
Minimum of 3 years' experience in management; prior people leadership role
Ability to lead multi-discipline engineering project teams
Experience assigning resources and managing schedules to completion
Experience in Systems Engineering, Architectural Design, and Project Management.
Must have strong verbal and written communication skills
Proficiency with modern CAD, CAE and other design / simulation tools
Proficiency with systems engineering and requirements management
Experience working in FDA regulated environment.
Willingness to travel (global) up to 10% of time
Deep experience in the selection and/or design and commercialization of parenteral drug delivery devices in the Biotech industry.
Strong working knowledge of current standards and regulatory expectations for injection device and combination product development, filing and commercialization.
GD&T (geometric dimensioning and tolerancing)
Minitab or equivalent statistical analysis software
Technical Project planning
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