BD (Becton, Dickinson and Company) Technology Lead - Rubber in Franklin Lakes, New Jersey

Job Description SummaryThe Senior Staff Engineer will bring advanced engineering skills and leadership skills to R&D activities related to single use disposable products. The candidate will play a lead role in managing and driving the technology development and product development activities related to development of elastomeric components in multiple medical device products. The individual must be able to demonstrate an expertise in various aspects of formulation and manufacturing process development including applied knowledge of raw material sourcing, compounding, analytical evaluations, mixing, extrusion, calendaring, molding, trimming, washing, lubrication and sterilization. Formulation and manufacturing expertise/experience must be within the medical device field and small component manufacturing. Core competences should reside in traditional thermoset rubber including but not limited to polyisoprenes, SBR’s, EPDM’s, and Butyls. Additionally knowledge of plastics, LSR and TPE materials is required. Most importantly the individual needs to be “hands on”, while still being able to maintain the ability to steer and guide individuals to ensure project success across multiple business segments and manufacturing locations.

The candidate will play the lead role in managing cross-disciplinary and cross-functional teams as well as external partners in developing single use disposable products for DC. This candidate must have a strong engineering design background in high volume disposables, with expertise in tolerance analysis and design for manufacturing. This candidate must have proven experience in bringing new products to market in a structured environment for product development and demonstrate proficiency with design controls and stage-gate processes. This candidate must be able to collaborate with all team members and be able to influence team members and stakeholders towards common goals. This candidate must have strong experience in managing budgets and timelines. This candidate must be able to work with manufacturing and other functions to ensure the design solutions are viable at high volume production. This candidate will also be responsible for identifying new processes or new trends with single use disposable manufacturing for molding, and for maintaining an overview of relevant technologies and products.

Candidates should be prepared to present previous product engineering work during the interview process to demonstrate their abilities and experience.

Job Description

  • As the Rubber Technical Lead, the Senior Staff Engineer’s primary role will be to drive innovation and ensure technical excellence in all aspects of product development related to elastomeric components for medical devices.

  • Lead a cross-disciplinary team of experts to develop and launch single use disposable products. The candidate will be responsible for identifying, developing and delivering innovative and practical solutions in alignment with the product development road map for implementing manufacturing solutions.

  • Maintain the yearly budgets and timelines on an ongoing basis and report periodically to the leadership team.

  • Collaborate with R&D to successfully create specifications, design, and test methods for the new products.

  • Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions.

  • Lead phase-gate related activities including technical reviews.

  • Provide technical guidance on issues that impact form/fit/function of the product

  • Lead rubber formulation and compounding efforts across BDX

  • Utilize hands on experience to perform equipment startup and debug efforts

  • Perform material characterization assessments

  • Stay up to date on relevant medical device regulations

  • Perform gap analyses and accurately project resource and equipment needs

  • Develop project budgets

  • Process effectiveness: Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities.

  • Innovation: Develop creative and novel solutions to technical problems.

  • Customer focus: Develop understanding of customer needs and processes to ensure relevant and innovative product development solutions.

  • Continuous learning: Actively seek training to improve skills. Ensure technical lessons are reviewed, learned, and disseminated. Actively teach and promote learning.

  • Ensure compliance with BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.

  • Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures.

Experience and Education

  • Must have a Master’s degree in a technical field preferably in Chemical Engineering/Polymer Engineering with at least 12 years of working in a medical device industry with proven record for launching products

  • Must have at least 8-10 years relevant experience in polymeric material development and process design.

  • Previous supervisory experience required

  • Must have a strong leadership skills to lead a cross functional technical team of associates.

  • Must have at least 5 years working experience in plastics/polymers used in medical device industry with preferable specialization in single use disposable devices and most preferably with rubber formulations

  • Must have experience in compression molding

  • Must have a Six Sigma background in Design Methodologies for medical device components.

  • Must have strong project management and budgeting background in R&D or manufacturing environment

  • Must have a strong background in design and tolerance analysis of plastic components in molding and assembly

  • Strong analytical and problem solving skills, as well as a good background in product development/manufacturing process specifically in high volume molding operations

  • Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams

  • Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes

  • Experience in fixture creation & development and test method development, implementation and validation for medical device/system

  • Highly desirable to have experience in mechanical test systems such as Instron for measuring forces, speed, and pressure

  • Solid understanding of statistical concepts such as in measurement system analysis and validation

  • Must have hands on experience in assembling prototypes and bench top systems for test equipments.

  • Proficient in Microsoft office products with emphasis on Excel, and Word.

  • Excellent problem-solver, critical-thinker, and decision-maker

  • Rubber formulation chemistry and compounding

  • Rubber manufacturing technologies for medical device components

  • Hands on experience utilizing rubber manufacturing equipment including startup and troubleshooting

  • Material characterization techniques and usage with regards to rubber materials

  • Medical device regulations and a specific know how related to elastomeric materials

  • Major vendors and raw materials and manufacturing equipment related to medical device elastomeric materials

  • Third party vendors for analytical support, component sourcing and turn-key applications

  • Ability to translate material inputs to molded product performance for various medical device applications

  • Ability to develop and financially model operations both internal and external specific to rubber manufacturing of small components

  • Ability to train technicians and engineers on various technologies and techniques linked with rubber manufacturing, compound development and analytical evaluations

  • Ability to translate and summarize information to persuade senior leadership with regards to sourcing strategies

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Primary Work LocationUSA NJ - Franklin Lakes

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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