Spectrum Plastics Group, A DuPont Business
Senior Process Engineer
Spectrum Plastics Group, A DuPont Business, Pleasant Prairie, Wisconsin, United States, 53158
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Senior Process Engineer
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Spectrum Plastics Group, A DuPont Business
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Description 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.
Location: Pleasant Prairie, WI.
Reporting To: Sr. Director of R&D (NPI) – Fluids & Flexibles – Spectrum Plastics Group
Job Responsibilities:
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.
Qualifications:
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.
SolidWorks CAD experience.
Six Sigma Green Belt beneficial.
Willing to travel 20%.
Skills and Competencies:
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.
Additional Details:
Seniority level: Mid-Senior level
Employment type: Full-time
Industries: Medical Equipment Manufacturing
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Senior Process Engineer
role at
Spectrum Plastics Group, A DuPont Business
Get AI-powered advice on this job and more exclusive features.
Description 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.
Location: Pleasant Prairie, WI.
Reporting To: Sr. Director of R&D (NPI) – Fluids & Flexibles – Spectrum Plastics Group
Job Responsibilities:
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.
Qualifications:
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.
SolidWorks CAD experience.
Six Sigma Green Belt beneficial.
Willing to travel 20%.
Skills and Competencies:
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.
Additional Details:
Seniority level: Mid-Senior level
Employment type: Full-time
Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr