Job Overview

Responsible for the design, development, validation, transfer, optimization, and sustained performance of polymer extrusion and downstream manufacturing processes used to produce medical tubing, catheter components, and medical heat-shrink products. The Senior Manufacturing Engineer will apply advanced knowledge of polymer materials, rheology, extrusion, thermal processing, heat-shrink expansion and recovery, and material-process-property relationships to develop stable, repeatable, and scalable manufacturing processes. The position will provide technical direction for new product introduction, manufacturing transfers, process troubleshooting, equipment and tooling development, process validation, and continuous improvement. This position works under general direction and exercises independent technical judgment when resolving complex manufacturing problems. The Senior Manufacturing Engineer will collaborate with Operations, Quality, Maintenance, Research and Development, Supply Chain, EHS, suppliers, customers, and other manufacturing sites. The individual may also train and coach operators, technicians, and less-experienced engineers.

Job Requirements

• Lead the design, development, characterization, and optimization of polymer extrusion processes for tight-tolerance medical tubing and catheter-related components.
• Develop and improve downstream manufacturing processes associated with medical heat-shrink tubing,
• Develop a scientific understanding of the relationship between polymer properties, material condition, equipment configuration, tooling design, and process parameters.
• Support the selection and evaluation of polymers used in medical tubing and heat-shrink applications, including PEBAX, nylon, polyurethane, polyethylene, other polyolefins, FEP, PFA, and related medical-grade materials.
• Coordinate or perform testing of polymer materials and finished products.
• Lead structured troubleshooting of extrusion and downstream manufacturing issues, including dimensional instability, wall-thickness variation, concentricity variation, surface defects, gels, contamination, pinholes, die lines, line breaks, surging, melt fracture, material degradation, expansion blowouts, slacking, uneven expansion, and recovery failures.
• Apply engineering fundamentals, polymer science, rheology, heat transfer, statistical analysis, and equipment knowledge to differentiate material-, machine-, tooling-, method-, measurement-, and operator-related causes.
• Lead root-cause investigations using appropriate methodologies such as DMAIC, A3, 8D, Design of Experiments, fishbone analysis, fault-tree analysis, and five-why analysis.
• Develop, implement, and verify corrective and preventive actions associated with nonconformances, CAPAs, audit findings, manufacturing deviations, and customer complaints.
• Plan, author, execute, and report equipment and process qualification activities, including Installation Qualification, Operational Qualification, and Performance Qualification.
• Develop statistically and scientifically justified validation strategies, sampling plans, acceptance criteria, and process-capability requirements.
• Execute or support Test Method Validation and measurement-system analysis for dimensional, mechanical, thermal, visual, and functional inspection methods.
• Lead or support the transfer of products, equipment, tooling, and manufacturing technology between facilities.
• Create and maintain Process Development Reports, technical reports, process specifications, setup sheets, Technical Instructions, work instructions, PFMEAs, control plans, validation protocols, validation reports, and troubleshooting guides.
• Apply Design of Experiments, Statistical Process Control, process-capability analysis, regression, hypothesis testing, and other statistical methods using Minitab or equivalent software.
• Identify and implement opportunities to improve safety, first-pass yield, process capability, throughput, labor efficiency, material utilization, equipment effectiveness, lead time, delivery performance, and Cost of Poor Quality.
• Provide technical training and coaching to operators, technicians, and engineers on equipment setup, material behavior, process controls, troubleshooting, and standardized work.
• Translate individual and subject-matter-expert knowledge into controlled, repeatable, and transferable manufacturing knowledge through written procedures, technical reports, images, videos, training materials, and practical demonstrations.

What your background should look like

• Bachelor’s degree in Polymer Engineering, Plastics Engineering, Materials Science and Engineering, Mechanical Engineering, Chemical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related engineering discipline, with at least five years of relevant experience; or
• Master’s degree in a related engineering discipline with at least three years of relevant experience; or
• Doctoral degree in a related engineering discipline; or
• An equivalent combination of education and directly relevant technical experience.
• Demonstrated hands-on experience developing, optimizing, or sustaining polymer extrusion processes.
• Experience applying polymer rheology and material-property-processing relationships to manufacturing problems.
• Experience with process validation, including IQ, OQ, and PQ activities.
• Experience with Design of Experiments, Statistical Process Control, process capability, PFMEA, and root-cause analysis.
• Experience investigating manufacturing nonconformances and implementing corrective actions.
• Experience authoring technical reports, manufacturing instructions, validation documentation, and controlled specifications.
• Working knowledge of ISO 13485, cGMP, and applicable medical-device quality-system requirements.
• Proficiency with statistical analysis software such as Minitab.
• Ability to work independently, manage multiple technical priorities, and lead cross-functional projects.
• Strong written, verbal, analytical, and technical-presentation skills.

Competencies