Manufacturing Engineer

Polyzen, part of the Solesis family of companies, develops and manufactures customized polymer-based materials, including extruded and molded components, and device assemblies that help innovators turn bold ideas into lasting breakthroughs. Operating in Apex, North Carolina, USA, Polyzen employs more than 75 team members.

Guided by a commitment to innovation, quality and customer success, Polyzen collaborates with customers to solve complex polymer challenges and bring new technologies from concept to commercialization. Employees play a vital role in advancing solutions that enable innovation and positively impact lives around the world.

The Manufacturing Engineer plays a key role in supporting manufacturing operations by taking process ownership through activities such as troubleshooting, root cause analysis for non-conformances and customer complaints, documentation, validations, and continuous improvement projects. This role will also support product development and the introduction of new products into manufacturing.

• →Supports the day-to-day manufacturing operation as a process owner to ensure process stability and conformance to customer specifications.
• →Evaluate and improve manufacturing methods, utilizing knowledge of product design, materials, fabrication processes, tooling and equipment capabilities, assembly methods, and quality control standards.
• →Evaluate equipment and processes for repeatability and make improvements as necessary, troubleshoot equipment as needed.
• →Track manufacturing yields and run rates; maintain accuracy of product bill-of-materials and routings within the ERP system.
• →Interact with the Development team to ensure manufacturability and minimize the risks associated with new products transferred to commercial production.
• →Develop and run protocols including IQ, OQ, and PQ activities as required.
• →Create and revise documents such as Work Instructions, Preventative Maintenance procedures, and raw material / component specifications.
• →Analyze process data using statistical methods to ensure the process is both stable and capable.
• →Ability to read and interpret CAD or mechanical drawings.
• →Partner with Quality department to process change control documentation and participate in investigations as part of deviations and the Corrective Action process.
• →Analyze and plan workforce crew sizes, facility space requirements, workflow, and layout of equipment and workspace for maximum efficiency.
• →Partner cross-functionally with internal teams to determine product specifications, material needs, use of equipment, and quality standards to meet customer needs.
• →Document processes and train operators and other applicable personnel.
• →Support functional departments in reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), and Preventative Maintenance (PMs) documentation to make process improvements or appropriate revisions.

• Bachelor’s Degree in Engineering (Mechanical, Industrial, Chemical, Biomedical) or equivalent experience required.

• 1-3 years’ experience in an Engineering or similar role within a manufacturing environment.
• Demonstrated ability to lead and manage multiple projects with the ability to meet deadlines and stay within budget.
• Experience with plastic processing (preferred).
• Proficient computer skills using MS Office, MS Project, and strong spreadsheet skills. Experience with Minitab is a plus.
• Strong analytical, organizational, team-building, and communication skills.
• Experience working within an ISO 13485 and/or FDA regulated environment.
• Lean Manufacturing, Six Sigma, or Continuous Improvement methodology training (preferred).