Sr. Extrusion Engineer

* Please note - Sponsorship is not available for this role

About us:

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!

Position Summary:

We are actively looking for a Senior Mechanical Engineer who can bring innovation and creative thinking to the team. As a Senior Mechanical Engineer, you will lead product development teams to bring complex designs from concept to market. You will play a key role in the development of novel medical devices including state of the art minimally invasive catheter-based devices, delivery systems for implants, and other complex medical devices.

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.
• 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.

This is not a remote 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.

Must Have:

• 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
• Mu