Sr. Extrusion Technician - 2nd shift

Cirtec Medical; Minneapolis (MN); On-site; USD 41,000 - 51,000; Full time

Benefits offered by this job

Healthcare and well-being programs

Paid Time Off

401(k) retirement savings with company

Job summary

Cirtec Medical is seeking a Sr. Technician, Extrusion for the 2nd shift (3:30PM–2:00AM, Mon–Thu) at the Brooklyn Park, MN facility.

You will operate extruders, develop and improve processes to meet customer specs, and help design tooling and fixtures for production. Qualified candidates have 3+ years extrusion experience in a regulated medical device setting, with ISO QMS experience and IQ/OQ validation knowledge, and strong English communication skills.

Qualifications

• Extrusion experience in a medical device or highly regulated manufacturing setting.
• Experience with ISO Quality systems and World Class Manufacturing principles.
• Ability to communicate effectively in English (verbal & written).
• IQ/OQ validation experience.

Responsibilities

• Read and interpret order specifications to determine machine adjustments and material requirements.
• Set up extrusion equipment and run orders per approved parameters during shift.
• Ensure resins are available and staged for usage.
• Adjust tooling and processing parameters to meet specifications within approved ranges.
• Inspect products and measure dimensions to verify machine performance.
• Provide process training to production operators and update ECN documentation.
• Perform IQ/OQ and validations and support root-cause investigations.

Skills

Extrusion

Communication

IQ/OQ Validation

Education

High School Diploma, GED or equivalent

Job description

Description

Shift: 2nd shift; 3:30PM - 2:00AM, Monday to Thursday

Location: NC1 Facility located at 8609 Xylon Court North, Brooklyn Park, MN 55445

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

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 challenges, you may be a perfect fit for our team!

Position Summary:

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.

Key Responsibilities:

• 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.

Must Have:

• High School Diploma, GED or equivalent
• 3+ years Extrusion experience
• 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

Hourly Pay Range:

$30 - $37 hourly, plus $2 shift differential, based on experience and qualifications

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work.

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