BD (Becton, Dickinson and Company) R&D Sr. Staff Engineer, Innovation and Product Development (Advanced Drug Delivery Devices, Combination Products) in Franklin Lakes, New Jersey
Job Description Summary
BD is in search of a talented R&D Sr. Staff Engineer looking to take previous development experiences with wearable infusion pumps, large volume injection devices, or the like to the next level.
As a R&D Sr. Staff Engineer with BD’s Pharmaceutical Systems, Self-Administration Injection Systems (SAIS) team in Franklin Lakes, NJ, you will have the opportunity to take a hands-on technical leadership role on a cross functional project core team guiding 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.
This position will perform as a technical leader on project core teams and contribute as a proponent of technical excellence while representing the organization as a key technical contact to external pharma-partners. In addition to technical leadership, this associate will be responsible for managing a R&D technical project plan to ensure key R&D milestones are achieved on time and on budget while helping to identify and mitigate technical risks. Finally, this individual will be asked to coach junior level engineers toward technical excellence.
What you get to do every day:
Deliver on new and innovative drug delivery solutions as a technical leader on a cross-functional project team through all phases of the project lifecycle, from concept through launch.
Represent the organization internally and externally as a technical subject matter expert in the field of combination product development.
Translate business requirements into a robust, scalable technical design.
Pursue complex problems by applying sound engineering principles utilizing experimental, computational and analytical methods to a range of technical product development challenges.
Work closely with both functional and project managers to identify and mitigate technical issues to reduce programmatic risks.
We are looking for a technical leader who can:
Guide multi-function teams comprising of QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members by facilitating effective communication and engagement.
Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications.
Demonstrate excellent interpersonal communication skills, which enable you to gain client trust and mentor junior engineers.
Apply and assert DFSS best practices on all projects
Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety laws, policies and procedures.
You will be effective if you have:
History of leveraging DFSS principles in the development/launch of medical product(s) through a phase gate development cycle in an ISO13485 environment (or equiv.).
Ability to understand/communicate theory of operation (engineering math and physics) for complex mechanical design and ability derive the correlation between functional inputs and performance outputs to achieve design robustness and optimization
A propensity to quickly learn new concepts and technologies and convert them into customer solutions.
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.
Must have a Bachelor of Science Engineering or technical degree. A concentration in mechanical engineering with a post graduate degree is preferred.
Minimum of 15 years related work experience required (or combination of work experience and advanced degrees).
Minimum of 5 years’ related work experience in medical device development with an emphasis on wearable infusion pumps, large volume injection devices, or the like.
Deep experience in the selection and/or design and commercialization of parenteral drug delivery devices in the Biotech industry.
Proven track record of executing complex system designs incorporating mechanical subsystems, preferably in the medical device field
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
Proficiency with systems engineering and requirements management
Technical Project planning
Primary Work Location
USA 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, or any other protected status.