Senior Principal Engineer, Plastics Molding — Pharmaceutical Manufacturing & Medical Devices

Position Overview
Full-time | Hybrid
The Senior Principal Engineer, Plastics Molding provides enterprise-level technical leadership for plastic injection molding and blow molding technologies supporting pharmaceutical manufacturing, medical devices, biologics, healthcare, and closely related regulated products. This role leads complex engineering initiatives across the product and process life cycle, advancing robust, compliant, scalable molding solutions through close partnership with internal stakeholders and external suppliers.
Key Responsibilities
Lead medium- to large-sized, complex molding engineering projects from concept and design through procurement, qualification, validation, and sustained support.
Develop and implement technically sound injection- and blow-molding solutions that meet product, process, quality, cost, and regulatory expectations.
Provide technical direction on equipment, tooling, automation, resin selection, process development, inspection strategy, and manufacturing readiness.
Conduct risk assessments, manage life-cycle costs, and communicate technical recommendations, project status, and risk-based decisions to management.
Support supplier selection, supplier performance, and technical issue resolution for molds, equipment, automation, and related services.
Technical and Functional Accountabilities
Apply deep knowledge of plastics processes, resins, injection molding equipment, blow molding, tooling, and inspection procedures to optimize process capability and product quality.
Plan and execute FMEAs, design of experiments (DOE), dimensional analysis, statistical process control (SPC) analysis, factory acceptance testing (FAT), equipment and process qualification, and validation activities.
Translate design controls, quality-system expectations, regulatory requirements, and applicable ISO requirements into practical engineering deliverables and manufacturing controls.
Lead or support tooling and automation design, procurement, qualification, and supplier management; evaluate technical proposals and acceptance criteria.
Use metrology and dimensional data to investigate variation, establish process controls, and drive effective corrective technical actions.
Maintain working familiarity with CNC equipment, wire EDM, surface finishes, grinders, hand tools, and 3D CAD platforms including SolidWorks, Creo/ProE, and AutoCAD.
Candidates are considered based on relevant qualifications, skills, and experience. The role welcomes a diverse range of backgrounds and perspectives consistent with applicable equal employment opportunity principles.
Leadership and Collaboration
Serve as a recognized technical resource, providing clear, evidence-based guidance on molding technology, manufacturability, risk, quality, and life-cycle decisions.
Partner effectively with cross-functional teams and external collaborators, including manufacturing, quality, engineering, procurement, suppliers, and service providers.
Influence technical alignment across stakeholders, facilitate resolution of complex issues, and enable timely execution in a regulated operating environment.
Communicate complex engineering concepts clearly to technical and non-technical audiences and advise management on options, tradeoffs, and recommendations.
This is a hybrid role based in North Chicago, Illinois. Work may include collaboration across office, manufacturing, supplier, and project environments.
Travel up to 40% may be required to support suppliers, equipment and tooling activities, factory acceptance testing, qualification, validation, and cross-functional project needs.
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Bachelor’s degree in Mechanical Engineering, Plastics Engineering, Engineering, Science, or a related field; equivalent technical experience may be considered.
10+ years of significant engineering and/or operational experience, preferably in pharmaceutical manufacturing, medical devices, biologics, healthcare, or another closely related regulated industry.
3+ years of plastic injection molding and/or blow molding design and process-support experience.
Demonstrated knowledge of molding equipment, plastics processes and resins, tooling, inspection procedures, SPC analysis, and applicable regulatory and ISO requirements.
Demonstrated experience with tooling and automation design; procurement and qualification; supplier management; FMEA, DOE, dimensional analysis, FAT, validation, design controls, metrology, and quality systems.

Employment type
Full-time

Work arrangement
Hybrid