Sunlite Plastics, Inc. is hiring: Manufacturing Engineer in Town of Germantown

Overview

Sunlite Plastics, Inc. has an exciting opportunity in our Medical Tubing Division in Wisconsin for a Manufacturing Engineer. The Manufacturing Process Engineer will be a key technical leader who will advance the technical skills and competencies of the extrusion engineering organization. Responsibilities include leadership for projects and technical support in new product launches, value improvement programs, process validations (IQ, OQ, PQ), product & equipment improvement, tooling design, process development, and product transfers between facilities. The role also involves developing new and cost-effective manufacturing concepts, training production associates, and engaging maintenance personnel in resolving process, material, tooling and equipment problems through systematic troubleshooting, root cause analysis, and irreversible corrective action implementation.

Note: knowledge of ISO 13485 and GMPs is a plus but not required.

Responsibilities

• Process Development
• Develop, test and optimize manufacturing and extrusion processes for new and existing products to reduce operating costs, labor, product variability and to increase yields.
• Assist in designing, building, assembling, debugging and optimizing manufacturing equipment, extrusion tooling, and secondary equipment for new and existing products.
• Develop machine specifications, identify and evaluate suppliers, procure, install and debug equipment for general manufacturing, extrusion equipment, and secondary processes.
• Plan, coordinate, develop and execute test protocols, experiments, process characterization and process validations on new and revised products and processes.
• Coordinate efforts to design, develop and validate manufacturing processes using DOE, MSA, FMEA, SPC, and capability analysis.

• Manufacturing Operations Support
• Provide timely resolution of product, process and equipment problems with short- and long-term solutions.
• Provide technical support and troubleshooting for manufacturing and extrusion operations.
• Monitor manufacturing variances to identify problem solving and improvement opportunities.
• Assist in transfer of technologies to maintenance and other technical staff.
• Assist in achieving manufacturing objectives.

• Project Management
• Lead cross-functional teams for value improvement projects, product transfers, new products, and manufacturing support projects.
• Generate project schedule, cost and performance targets, and track/report progress to meet overall objectives.
• Prioritize and balance workload of multiple project assignments based on business and functional objectives.

• Technical
• Remain current in materials, equipment, extrusion, design for manufacturing, DOE, product development process, and process/test method validations (IQ, OQ, PQ, TMV).
• Consult or provide technical advice to team members on product and process issues.
• Identify, analyze and provide financial details for potential value improvement opportunities and product improvements.

• QA/RA
• Stay current with QA/RA SOPs on all projects, including equipment development, product development, process controls, process validations, and the ECO system.
• Provide support as required to GMP, safety, ISO, and internal audits.

Education and Experience

• Bachelor's degree in Mechanical, Polymer, Plastics Engineering or related engineering discipline
• 4+ years in a manufacturing environment with demonstrated technical and relationship skills
• Strong initiative – self-directed and action-oriented

Skills/Knowledge

• Ability to persist on problems and willingness to work additional hours to accomplish goals
• Experience applying statistical analysis to problem solving and process optimization
• Experience creating and writing IQ/OQ/PQ validations, including test method validations
• Proficient in MS Office, MS Project, and Minitab
• Effective communication and strong organizational skills
• Employee benefits: Medical, Dental, Vision insurance; 401k with company match; paid vacations and holidays; employee assistance program

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Manufacturing

Industries

• Medical Equipment Manufacturing

This job description reflects information about the role and is intended for applicants to understand the responsibilities and qualifications. EEO statements and standard company information may apply as required by law.