Staff Engineer Material Engineering; Hybrid, Franklin Lakes, NJ

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Staff Engineer, TPE Industrialization and Manufacturing Scale-Up leads the technical effort to move thermoplastic elastomer (TPE) formulations from development-scale feasibility to reliable, validated, and commercially balanced manufacturing processes. This position stands out by focusing on turning innovative formulations into outstanding manufacturing operations.

TPE Industrialization and Expansion Lead industrialization of primary and backup TPE formulations from laboratory development through pilot-scale and production-scale manufacturing. Develop and complete scale-up strategies for compounding, pelletizing, molding, finishing, sterilization, assembly, packaging, and storage. Establish robust manufacturing process windows and document relationships among formulation composition, processing conditions, component geometry, dimensional variation, and functional performance. Evaluate material behavior across multiple component sizes and determine whether a common formulation and process platform can be used or controlled size-specific optimization is required.

Lead prototype and engineering builds using representative molds, equipment, materials, and operating conditions. Characterize shrinkage, dimensional stability, rheological behavior, friction, stress relaxation, compression set, sterilization response, process sensitivity, and lot-to-lot variability. Use DOE, Gage R&R, measurement system analysis, regression, process-capability analysis, and risk-based sampling. Translate development findings into manufacturing controls, operating ranges, setup requirements, inspection methods, and acceptance criteria. Support equipment qualification and process validation, including technical definition of IQ, OQ, and PQ strategies.

Lead structured root cause investigations and implement technically justified corrective actions. Supplier and Material Control Deliver technical direction to TPE compounders, molders, contract manufacturers, raw-material suppliers, and testing partners. Assess supplier formulation capability, manufacturing controls, quality systems, technical documentation, and scale-up readiness. Establish expectations for formulation ownership, raw-data access, sample genealogy, material traceability, certificate-of-analysis content, and supplier change notification. Develop and maintain material buy specifications, including critical properties, allowable ranges, acceptance criteria, incoming inspection requirements, and change-control expectations.

Evaluate the effect of raw-material, formulation, equipment, tooling, site, and process changes on product performance and regulatory commitments. Identify industrialization risks early and develop evidence-based mitigation and contingency plans. Product and Process Performance Establish KPIV/KPOV relationships linking material and processing variables to component dimensions, friction, pump force, hand control, break-loose, breakout, leakage, reflux, compliance, flow-rate accuracy, and manufacturing robustness. Partner with product engineering to translate device requirements and material-component-device interfaces into material and process…