Engineer 2, Combination Product Testing

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 DescriptionPosition Title: Engineer 2, Combination Products (Branchburg, NJ) Reporting Structure: As per current organizational chart Position Summary: As part of the BD/ZebraSci Combination Product Services team, the Engineer 2, Combination Products, will assist with 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 helps implement new testing technologies. 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. Essential Duties and Responsibilities Uses technical expertise to contribute to the customer sales process, service delivery, and maintains a customer-focused outlook: Supports the Combination Product Services team to accurately collect, analyze, challenge, and synthesize customer requests/inputs and translates these into appropriate responses, solutions, services, and action plans Educates on technical aspects of combination products and testing services as appropriate: Advises on service and/or product solutions for needs Answers technical questions Aids in the scoping of testing approaches, fixturing, protocols, and method validation and in the timely delivery of projects to customers Closely coordinates with internal cross-functional team (business development, quality, service operations) to discuss and resolve challenges with service projects, and provide updates Develops training modules, videos, or other materials as appropriate on ZebraSci products, services, and/or processes Develops, maintains, and diffuses combination product services technology: Supports technical initiatives related to combination products testing services, methodologies, and instrumentation. Stays abreast of changing regulations, standards and environment relevant to combination products and impacting the component, medical device, and pharmaceutical industries Implements new programs, tests, methods, instrumentation, and procedures. With minimal supervision, plans and performs experiments that support new product or technology feasibility testing. Develops new methodologies or conducts routine procedures as needed. Interfaces with machine shop to execute fixturing development and fabrication to support experimental designs, and performs testing of product produced experimentally as required. 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/machine makers, vendors, or other 3rd party entities Effectively communicates, orally and written, project progress and results both within the team and to the customers Skilled in effectively presenting/communicating performance results/test outcomes Clearly understands how to assimilate large amounts of data into understandable and concise presentations Demonstrates superior planning and organization skills to balance a multitude of projects and clients simultaneously Capable of translating activities and tasks into an actionable plan Effectively communicates timely, accurate and reliable reporting on progress against project deliverables Provides guidance to lab staff when needed Understands documentation requirements per cGMP Able to troubleshoot and provide technical assistance for Root Cause Investigations Supports the Services Technology Development Manager, as needed Performs other duties as required. Required Skills/Experience Degree in Engineering or related technical field with experience supporting medical device or combination product testing. Will consider 7+ yrs experience within Combination product testing in lieu of education. 4+ yrs in test method development/validation, experimental design, bench testing, data analysis, and troubleshooting. Knowledge of cGMP requirements and ability to support root cause investigations while working effectively across cross-functional teams. Preferred Skills/Experience Experience with Container Closure Integrity (CCI) testing, drug-device combination products, injectable delivery systems, or pharmaceutical testing environments. Hands-on experience with fixture design, laboratory instrumentation, and implementation of new testing technologies. Knowledge of FDA, ISO, USP, and combination product regulations and standards. Customer-facing technical experience with project management, technical presentations, and client support. 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, pos