Senior Process Engineer

The Sr. Process Engineer – Flexibles is responsible for Execution and implementation of projects of great impact for the organization, related to R&D and New Product Introduction. We are seeking a highly skilled and innovative Senior Process Engineer to lead process development, optimization, and technical innovation in blown film extrusion and converting for medical device and medical packaging applications. This role is central to our R&D and New Product Introduction (NPI) initiatives, supporting cutting-edge projects from concept through commercialization while ensuring compliance with regulatory standards and industry best practices.

The ideal candidate will bring deep expertise in polymer processing, film manufacturing, and converting technologies, coupled with experience in regulated environments (ISO 13485, FDA, GMP). Will work cross-functionally with R&D, Quality, Manufacturing, and Commercial teams to drive product and process excellence.

Location: Pleasant Prairie, WI.

Reporting To:  Sr. Director of R&D (NPI) – Fluids & Flexibles – Spectrum Plastics Group

Job Description:

Process Engineering & Development

• Supports Engineers, technicians and operators during process development work.
•  Lead the design, development, and optimization of blown film extrusion processes for multilayer medical-grade films.
• Define and implement process parameters, tooling design, material selection, and quality control strategies.
• Develop robust converting processes (slitting, printing, pouching, laminating, etc.) tailored for sterile barrier systems and medical device packaging.

Research & Development (R&D)

• Drive process innovation to support new materials, multilayer film structures, and proprietary packaging technologies.
• Collaborate with product development teams to ensure process capabilities align with product performance requirements and regulatory expectations.
• Conduct trials and scale-up activities to validate new materials and processes on pilot and production lines.

New Product Introduction (NPI)

• Serve as the technical lead during the NPI lifecycle, from feasibility to design transfer and commercialization.
• Develop and execute process validation (IQ/OQ/PQ), design of experiments (DOE), and risk assessments (PFMEA).
• Provide hands-on support for equipment commissioning, tooling procurement, and technology transfer.

Quality & Compliance

• Ensure processes and documentation comply with ISO 13485, FDA 21 CFR Part 820, and applicable medical packaging standards (e.g., ISO 11607).
• Collaborate with Quality and Regulatory Affairs to develop and maintain technical files, validation protocols, and work instructions.
• Support root cause investigations, CAPA, and continuous improvement initiatives.

Project Management & Leadership

• Manage multiple technical projects concurrently with minimal supervision.
• Mentor junior engineers and technicians; promote knowledge sharing and best practices.
• Interface with suppliers, equipment manufacturers, and customers to support technical objectives.

Candidate Requirements:

• Bachelor’s degree in engineering or scientific discipline.
• 7 years of relevant experience in process engineering, with a strong focus on blown film                                                   extrusion and film converting.
• At least 3 years of direct experience in a Medical Device or Healthcare packaging environment.
• Expert level experience with integrated extrusion systems, Test Method development, protocol generation, execution, and reporting.
• Proven track record in R&D and NPI projects within a regulated manufacturing setting.
• GMP and ISO 9000 training.
• Experience with tooling design with advanced SolidWorks CAD knowledge.
• Six Sigma Green belt or equivalent certification beneficial but not required.
• 20% travel.

Competencies/Skills

• Self-motivation and hands-on skills to simplify complex processes.
• Professional experience in exploration of new technologic prospects.
• Capability to establish change and encourage the inter-organizational exchange of skills.
• Exceptional problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision-making.
• In-depth knowledge of blown film extrusion (co-extrusion, die design, resin rheology, cooling, winding).
• Proficiency in converting processes such as slitting, die cutting, heat sealing, laminating, and pouch manufacturing.
• Strong understanding of polymer behavior, film characterization, and testing methods.
• Experience with statistical analysis tools (Minitab, JMP), DOE, SPC, and process validation methodologies.
• Familiarity with medical packaging standards such as ISO 11607, ASTM F88, F1929, etc.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Demonstrated leadership and project management capabilities.
• Experience with cleanroom manufacturing and Class I/II/III medical device packaging.
• Knowledge of sustainability trends in polymer materials and biodegradable films.
• Experience with ERP and document control systems (e.g., IQMS, Agile).