bb7 is looking for an experienced Extrusion Engineer to work with one of our medical device clients in the Metro Milwaukee area. This is a direct-hire position with the client.
There is an exciting opportunity in our Medical Tubing Division in Wisconsin. We are looking for a Sr. Mfg. Process Engineer to join our team. The Sr. Mfg. Process Engineer will be a key technical leader who will substantially advance the technical skills and competencies of the extrusion engineering organization. He/She provides leadership for projects and technical support to the company in the areas of new product launches, value improvement programs, process validations (IQ, OQ, PQ), product & equipment improvement, design of tooling, process development, and product transfers between facilities. Additionally, the Sr. Mfg. Process Engineer will be responsible for the development of new and cost effective manufacturing concepts as well as the training of production associates, and the engagement of maintenance personnel in resolving process, material, tooling and equipment problems through the use of systematic methods of troubleshooting, root cause analysis, and irreversible corrective action implementation. The Ideal Candidate would have knowledge of plastic processing, material blending, compounding and extrusion – including extrusion downstream equipment such as puller/cutters, bonders, conveyors, take-up systems and packaging equipment. Moreover, the ideal candidate would have a working knowledge of ISO 13485 and GMPs.
- Develop, test and optimize manufacturing and extrusion processes for new and existing products that reduce operating costs, reduce labor, reduce product variability and increase yields.
- Assist in the design, develop, build, assemble, de-bug and optimize manufacturing equipment, extrusion tooling, and secondary equipment for new and existing products.
- Develop machine specifications, identify and evaluate suppliers, then procure, install and de-bug equipment from outside suppliers 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 tools such as Design Of Experiments (DOE), Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), and capability analysis.
Manufacturing Operations Support
- Provide timely resolution of product, process and equipment problems in the form of creative short and long term solutions.
- Provide technical support and troubleshooting for manufacturing and extrusion operations.
- Monitor manufacturing variances so that problem solving and improvement opportunities are identified.
- Assist in the transfer of technologies to maintenance and other technical staff.
- Assist in achieving manufacturing objectives.
- Lead cross-functional teams for value improvement projects, product transfers, new products, and manufacturing support projects.
- Generate project schedule, cost and performance targets, then perform tracking and reporting so that overall objectives are met.
- Prioritize and balance workload of multiple project assignments based on business and functional objectives.
- While leading and conducting projects, apply knowledge and remain current in the following areas: materials, equipment, extrusion, design for manufacturing, design of experiments (DOE), product development process, 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.
- Stay current with, and ensure that, appropriate QA/RA SOP’s are followed on all projects, including: equipment development processes, product development processes, process controls, process validations, and the ECO system.
- Provide support as required to GMP, safety, ISO, and internal audits.
Education and Experience
- Bachelors Level Degree in the Mechanical, Polymer, Plastics Engineering or other related engineering discipline.
- 5-10 years in a manufacturing environment with demonstrated technical and relationship skills.
- Strong initiative – self-directed and takes action on opportunities.
- Ability to stick with a problem until it is resolved and the willingness to work additional hours if needed to accomplish the goal.
- Successful experience in the application of statistical analysis towards problem solving and process optimization
- Experience creating and writing process/equipment IQ/OQ/PQ validations, including test method validations.
- Proficient in the following computer software applications: MS Office, MS Project and Minitab
- Ability to effectively communicate both internally and externally.
- Strong organizational skills.
bb7 and its Clients are equal opportunity employers and do not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, veteran status, marital status, disability, age, membership in an employee organization, or any other classification protected by federal, state, or local law. We participate in E-Verify.