Job Description Summary

The role of Staff Engineer involves, customer facing, technical leadership in 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, supporting our pharma partners, this role will give the opportunity to develop user-centric drug delivery solutions designed to drive patient empowerment, independence, compliance, and improved health outcomes.

Job Description

Staff Engineer

Day to Day responsibilities:

• Deliver 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, from concept through launch.
• Represent the organization as the prime technical contact to a pharma partner on a B2B product development project.
• 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 over a range of products from simple disposable components to complex electromechanical and “smart” device assemblies.
• Work closely with both functional and project managers to identify and mitigate technical issues to reduce programmatic risks.
• Improve product development cycles and quality via the application of DFSS and Lean Product Development Tools
• Develop and guide technical design/methodologies to achieve product goals,
• Mentor a team of R&D associates in best design practices, analysis, simulation and verification of subsystems and systems
   

Technical Leader capable of:

• 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
• Be an agile learner, tolerant of risk, and biased towards action
• Effectively and clearly communicate concepts, ideas and knowledge to other individuals, teams and customers
• Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety laws, policies and procedures.

Experience in the following:

• History of developing/launching medical product(s) through a phase gate development cycle in an ISO13485 environment (or equiv.).
• Expert knowledge in related technical fields
• Excellent analytical skills & discipline; able to conduct thorough analysis of concepts that have high uncertainty
• Intellectual drive to gain firsthand understanding of customer needs
• 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
• Ability to lead through building relationships; demonstrated facilitation skills across different functions; motivated by collective success
• Skilled communicator at all levels; able to translate complex technical concepts for non-expert audiences.
• History of working closely with functional and project managers to identify and mitigate technical issues to reduce programmatic risks
• Experience in guiding team/individuals to develop technical solutions to complex problems
• 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

Minimum Qualifications:

Education:

• Must have a Bachelor of Science Engineering or technical degree. A post graduate degree is desired.
• Minimum of 8 years related work experience required (combination of work experience and advanced degrees).

Experience:

• 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.
• Must have strong verbal and written communication skills, including customer interaction experience
• 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
• Ability to lead multi-discipline engineering project teams
• Proficiency with modern CAD, CAE and other design / simulation tools