Staff Engineer, TPE Industrialization & Scale-Up (Hybrid)

BD; New Jersey; Hybrid; USD 136,000 - 217,000; Full time

Benefits offered by this job

Medical coverage

401(k) Plan

Paid time off

Dental coverage

Job summary

BD in Franklin Lakes, NJ, is seeking a Staff Engineer for New Product Development. This hybrid onsite role requires leading the technical effort to move TPE formulations from development to scalable, validated manufacturing processes.

You will drive industrialization, scale-up strategies, process windows, and DOE-based analyses, partnering with R&D, Quality, Operations, and suppliers to deliver robust medical-device manufacturing solutions.

Qualifications

• 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.

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.
• 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.

Skills

DOE

statistical engineering

manufacturing scale-up

project leadership

Education

Bachelor's degree in materials science or related field

Master’s degree or PhD in materials science or related field

Job description

BD in Franklin Lakes, NJ, is seeking a Staff Engineer for New Product Development. This hybrid onsite role requires leading the technical effort to move TPE formulations from development to scalable, validated manufacturing processes.

You will drive industrialization, scale-up strategies, process windows, and DOE-based analyses, partnering with R&D, Quality, Operations, and suppliers to deliver robust medical-device manufacturing solutions.