Combination Products Senior Engineer at Becton Dickinson in Branchburg, NJ

Job description



 We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 Job Description Position Summary This position is reporting to the Technology Development Manager at ZebraSci in Branchburg, NJ. As part of the BD/ZebraSci Combination Product Services team, the Combination Products Senior Engineer will lead technical and scientific activities related to combination product test method development and execution and will serve as a technical contact for pharmaceutical customers and ZebraSci laboratory operations. This position performs technical analyses of drug delivery systems, designs fixturing, develops and validates test methods and testing equipment, implements new testing technologies, leads root cause investigation activities, and serves as a technical subject matter expert on equipment and testing modalities. S/he will plan, perform and analyze bench-level engineering tests or research experiments for drug-device combination products and medical devices. Position requires that candidate may perform tests to support operations. Responsibilities · Owns and drives development and validation of functional/mechanical test methods for combination products, including prefilled syringe (PFS), autoinjector (AI), safety devices (NSD), and on-body injector (OBI) products. · Supports technical initiatives related to combination products testing services, methodologies, and instrumentation. · Stays abreast of changing regulations, standards and environment relevant to combination products. · Implements new programs, tests, methods, equipment, instrumentation, and procedures. · Interfaces with machine shop to execute fixturing development and fabrication. · Uses technical expertise to contribute to the customer sales process, service delivery, and maintains a customer-focused outlook · Understands the technical needs and issues that customers are facing and translates customer requests into appropriate responses, solutions, services, and action plans with little to no supervision. · Educates customers and internal team on technical aspects of combination products and testing services. · Advises on service and/or product solutions for needs and answers technical questions. · Leads and/or aids in scoping testing approaches, fixturing, protocols, and method validation. · Develops training modules, videos, or other materials as appropriate. · Acts as liaison with machine makers, vendors, or other 3rd party entities · Establishes working relationships with external technology partners. · Maintains technical relationships with major equipment makers, vendors, or other third parties. · Can assimilate large amounts of data into understandable and concise presentations. · Understands documentation requirements per cGMP. · Able to troubleshoot and provide technical assistance for root cause investigations. · Assists in training activities for junior team members Performs other duties as required. Education, Experience and Skills · Strong knowledge of drug-device combination products and/or medical devices. · Strong knowledge of regulatory standard-driven data analysis and statistical approaches. · Knowledge of operation of mechanical measurement equipment, vision systems, and container closure integrity instrumentation. · Understanding of applicable regulatory requirements for combination products (e.g. ISO 11608, ISO 11040, ISO 13485) · Technical support for clients, and technical mentor for team members and junior associates. · Project management, prioritizing and multi-tasking skills. · Ability to effectively communicate concepts, ideas and kn