Senior Process Engineer
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Job Location:
Pleasant Prairie, WI - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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.
Qualifications
Candidate Requirements:
- Bachelors 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).
Required Experience:
Senior IC
Key Skills
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Tooling
- Statistical Software
- Process Engineering
- cGMP
- Programmable Logic Controllers
- Public Speaking
- Manufacturing
About Company
We are leaders in medical plastics design, development & manufacture, with over 2,000 employees, and 20 manufacturing locations worldwide.
