Staff Engineer Material Engineering (Hybrid, Franklin Lakes, NJ)

Becton Dickinson Medical Devices•Bridgewater, NJ

10d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree or equivalent experience in materials science, polymer science, chemical engineering, mechanical engineering, plastics engineering, or a related technical field.
Advanced technical experience in polymer or elastomer process development, manufacturing scale-up, molding, validation, or material industrialization.
Demonstrated experience applying DOE and engineering statistics to manufacturing or product-development problems.
Experience developing process windows, material specifications, validation strategies, and technically rigorous reports.
Strong written and verbal communication skills with suppliers, manufacturing teams, technical specialists, and senior leaders.
Proven ability to lead complex technical work across organizational and functional boundaries.

Nice To Haves

Master’s degree or PhD or equivalent experience in materials science, polymer science, chemical engineering, or a related field.
Experience with TPE, TPV, thermoset elastomers, rubber formulations, or injection-molded medical-device components.
Experience with regulated product development, build controls, risk management, and quality systems.
Experience supporting IQ/OQ/PQ, process validation, measurement system analysis, and build transfer.
Knowledge of sterilization, aging, extractables and leachables, biocompatibility, component-device interactions, or container-closure performance.
Experience coordinating technical interactions with compounders, molders, contract manufacturers, or external research partners.

Responsibilities

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.
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.
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 controls.
Support performance evaluation at initial condition and after sterilization and accelerated or real-time aging.
Define worst-case material, process, equipment, supplier, and component conditions for verification and validation.
Ensure industrialization decisions are supported by traceable data and clearly detailed engineering rationale.
Serve as technical authority for TPE manufacturing readiness and scale-up.
Lead cross-functional problem solving with R&D, Quality, Operations, Regulatory Affairs, Procurement, Product Engineering, and external suppliers.
Author and review protocols, reports, specifications, validation plans, technical assessments, risk analyses, design-control deliverables, and decision documents.
Maintain traceability from product requirements and material CTQs through process controls, test evidence, specifications, and risk controls.
Communicate complex findings clearly and directly for technical teams and leadership.
Mentor engineers and scientists in statistical engineering, industrialization, validation, root cause analysis, and technical documentation.