Sr. Extrusion Technician

Description

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!

The Sr. Technician, Extrusion position is responsible for the safe and functional operation of extruders and all downstream equipment. This position will be responsible for developing & improving current processes to manufacture products per customer specification, and assist in the development of required tooling & fixtures. The Sr. Technician, Extrusion must perform the duties below to meet production and/or development demands according to the established quality standards.

• Read & understand order(s) specifications to determine machine adjustments and material requirements.
• Set up machines and other required extrusion equipment according to the approved parameters to run order(s) during assigned shift.
• Ensure the needed resins are available and properly staged for usage, as needed.
• Adjust tooling and processing parameters as allowed within the approved range(s), to produce product that meet approved specifications.
• Inspect products according to approved methods and standards using approved equipment.
• Collect and package products according to approved standards and deliver to the next station.
• Observe machine operation to detect work-piece defects or machine malfunction.
• Measure work-piece dimensions to determine accuracy of machine operation.
• Perform minor maintenance on the machines, dies or work pieces, such as oiling, etc.
• Purge, shut down and clean equipment according to approved methods, as applicable.
• Adhere to Cirtec's Values, Quality and Safety standards, Policies & Procedures, including but not limited to:
  Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, and other regulatory requirements.
• Collaborate with customers, suppliers, and internal cross-functional team members to: support the development of specifications, coordination of prototype fabrication of customer designed parts, and the transition of prototypes into manufactured components.
• Provide support on the execution of project deliverables to meet established metrics.
• Support the investigation of root causes for product and process failures, and establish of corrective actions.
• Evaluate and recommend alternative manufacturing methods, per established guidelines.
• Assist Engineering to design tooling for production, and the development of manufacturing procedures.
• Provide process training to production operators, as needed.
• Update documentation as needed through ECN process.
• Perform IQ/OQ and Validations
• Train team members and new employee(s) on machines and department procedures, as needed.
• Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness, and safety.
• Reliable, consistent, and punctual attendance is essential and required for the position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

• High School Diploma, GED or equivalent
• 5+ years operating extruders in a medical device environment
• Medical device or highly regulated industry manufacturing background
• Experience with ISO Quality systems and World Class Manufacturing principles
• Must be able to communicate (verbal & written) and…