Combination Products Senior Engineer



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 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 knowledge. · Experience guiding teams to develop technical solutions to complex problems. · Experience writing programs on Instron, Zwick, Keyence, etc. · Knowledge of small-scale filling and component assembly is desirable. · Understanding of design control and system integration is desirable. · Experience in silicone or particulate analysis is desirable. · Experience with technical document generation, execution, and reporting. · Experience with test method development and validations (MSA, Gage R&R, etc.). · Knowledge of test fixture design and development. · Proficient in CAD (SolidWorks) for fixture design. · Knowledge of 3D printers for rapid prototyping and fixture development is desirable · Understanding of GD&T for creation of engineering drawings. · Application of statistical and analytical methods such as DOE, ANOVA, and statistical software. · Experience working in a cGMP environment is desirable · Superior communication skills, both written and oral. Bachelor's or Master's degree in a science or engineering discipline (e.g. mechanical, biomedical, chemical engineering) plus relevant experience related to combination product or medical device development and/or testing: · 4+ years of experience with a BS, preferred. · 2+ years of experience with a MS, preferred. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: Annual Bonus Health and Well-being Benefits Medical coverage Health Savings Accounts Flexible Spending Accounts Dental coverage Vision coverage Hospital Care Insurance Critical Illness Insurance Accidental Injury Insurance Life and AD&D insurance Short-term disability coverage Long-term disability insurance Long-term care with life insurance Other Well-being Resources Anxiety management program Wellness incentives Sleep improvement program Diabetes management program Virtual physical therapy Emotional/mental health support programs Weight management programs Gastrointestinal health program Substance use management program Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit Retirement and Financial Well-being BD 401(k) Plan BD Deferred Compensation and Restoration Plan 529 College Savings Plan Financial counseling Baxter Credit Union (BCU) Daily Pay College financial aid and application guidance Life Balance Programs Paid time off (PTO), including all required State leaves Educational assistance/tuition reimbursement MetLife Legal Plan Group auto and home insurance Pet insurance Commuter benefits Discounts on products and services Academic Achievement Scholarship Service Recognition Awards Employer matching donation Workplace accommodations Other Life Balance Programs Adoption assistance Backup day care and eldercare Support for neurodivergent adults, children, and caregivers Caregiving assistance for elderly and special needs individuals Employee Assistance Program (EAP) Paid Parental Leave Support for fertility, birthing, postp

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