Sr. Extrusion Engineer

Key Responsibilities

• Read & understand order(s) specifications to determine machine adjustments and material requirements.
• Adjust tooling and processing parameters as allowed within the approved range(s), to produce products that meet approved specifications.
• Interface with vendors for raw materials and equipment.
• Evaluate production equipment to ensure highest productivity and product quality.
• Observe machine operation to detect work-piece defects or machine malfunction.
• 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.
• Lead and or assist investigations of root causes for product and process failures, and establish of corrective actions.
• Evaluate and perform alternative manufacturing methods, per established guidelines.
• 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.

Requirements

• Read & understand order(s) specifications to determine machine adjustments and material requirements.
• Adjust tooling and processing parameters as allowed within the approved range(s), to produce products that meet approved specifications.
• Interface with vendors for raw materials and equipment.
• Evaluate production equipment to ensure highest productivity and product quality.
• Observe machine operation to detect work-piece defects or machine malfunction.
• 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.
• Lead and or assist investigations of root causes for product and process failures, and establish of corrective actions.
• Evaluate and perform alternative manufacturing methods, per established guidelines.
• 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.

Qualifications

• Must have a Bachelor's degree in Mechanical, Industrial, Biomedical, or related Engineering area OR equivalent combination of education and work experience.
• Minimum 5 years of extrusion experience.
• Demonstrated experience in extrusion, tooling, and machine maintenance and process.
• 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 comprehend English.
• IQ/OQ Validation experience.

Skills

• Strong problem-solving and critical thinking skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficient in CAD/CAM software.
• Knowledge of FDA regulations and quality management systems.

Benefits

• Training and career development.
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs.
• Paid Time Off.
• 401(k) retirement savings with a company match.

Pay

The pay range for this role is $100,000 - 150,000 a year. The successful candidate’s starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

Schedule

This is not a remote position. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above.