Senior Process Engineer

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The Sr. Process Engineer – Flexibles is responsible for the execution and implementation of impactful projects related to R&D and New Product Introduction. We are seeking a highly skilled 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 supports cutting-edge projects from concept through commercialization while ensuring compliance with regulatory standards and industry best practices.

Pleasant Prairie, WI.

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

• Support engineers, technicians, and operators during process development.
• 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 converting processes for sterile barrier systems and medical device packaging.
• Drive process innovation for new materials and multilayer film structures.
• Collaborate with product development teams to meet product and regulatory requirements.
• Conduct trials, scale-up activities, and validate processes.
• Ensure processes comply with ISO 13485, FDA 21 CFR Part 820, and ISO 11607 standards.
• Develop and maintain validation protocols, technical files, and work instructions.
• Manage multiple projects, mentor junior staff, and interface with suppliers and customers.

• Bachelor’s degree in engineering or scientific discipline.
• 7+ years in process engineering, with experience in blown film extrusion and converting.
• At least 3 years in a Medical Device or Healthcare packaging environment.
• Expertise in extrusion systems, testing, and protocol development.
• Experience in R&D and NPI in regulated manufacturing.
• GMP and ISO training preferred.
• Solid Works CAD experience.
• Six Sigma Green Belt beneficial.
• Willing to travel 20%.

• Strong problem-solving, organizational, and analytical skills.
• Deep knowledge of blown film extrusion and converting processes.
• Understanding of polymer behavior and testing methods.
• Experience with statistical tools and process validation.
• Excellent communication and leadership skills.
• Knowledge of medical packaging standards and cleanroom manufacturing.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Industries:
  Medical Equipment Manufacturing