Process Engineer - Extrusion

Cretex Medical Component and Device Technologies | Posted Mar 3

Full-time

Minneapolis

Negotiable

Entry (0-2 yrs)

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at

The Process Engineer - Extrusion will be responsible for the development and execution of select technical operations including the establishment of process parameters, support of validation activities, and troubleshooting production issues in a manufacturing facility. Responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes primarily Extrusion but including braiding, assembly, tipping, reflow, centerless grinding. This position will also provide direction and support for existing products including support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.

• Utilize engineering principles to establish capable processes for new and existing tooling including the use of modeling tools
• Serve as a Subject Matter Expert (SME) for extrusion processes, equipment, and materials
• Support adjacent catheter manufacturing technologies such as braiding, coil winding, polymer reflow, and catheter tipping
• Standardize and support set-up procedures and standard tools to continuously reduce set-up times
• Work with cross functional teams to support production transfers
• Develop, model and document processes that demonstrate the achievement of functional, financial, and quality goals
• Participate in the development of validation protocols in cooperation with Quality, Sales, and Operations functions
• Execute comprehensive OQ protocols that clearly define, demonstrate, and document process windows sufficient to achieve Process Capabilities that meet or exceed Customer’s and/or Cretex Process Capability requirements on critical to quality features
• Support the Quality team while they execute comprehensive PQ protocols that clearly define, demonstrate, and document process windows sufficient to achieve Process Capabilities that meet or exceed Customer’s and/or Cretex Process Capability requirements on critical to quality features
• Identify and support continuous improvement opportunities for processes that are performing below Cretex quality standards
• In collaboration with Quality, analyze weekly yield and inspection data to identify and resolve problem processes and tools
• In collaboration with Operations, analyze weekly delivery and productivity data to identify and resolve problem processes and tools
• Provide technical coaching and feedback to production employees and the support team
• Communicate with customers as necessary regarding technical details of Extrusion and validation process
• Partner with the other business segments sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets we serve
• Bachelor’s degree in Engineering or related field, or equivalent training and experience
• 3-5 years of experience in a related manufacturing environment
• Medical device extrusion experience
• Ability to read and understand quality plans
• Must possess the ability to troubleshoot issues using disciplined root cause analysis tools
• Understanding of a variety of Catheter assembly processes and secondary operations equipment
• Experience with multi-lumen extrusion, vacuum sizing, and contact sizing (preferred).
• Experience with R&D extrusions, development of new processes and specifications.
• Depth of knowledge in material and material grades for extrusions, understanding of thermal profiles, resin moisture monitoring.
• Strong Leadership skills
• Ability to consistently achieve short- and long-term business results
• Ability to follow through on commitments and holds team members accountable
• Strong problem-solving skills
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written…