Sr. Extrusion Technician

Cirtec Medical; Santa Clara (CA); On-site; USD 57,859 - 68,880; Full time

Benefits offered by this job

Training and career development

Healthcare and well-being programs

Paid Time Off

401(k) retirement savings with company match

Job summary

Cirtec Medical is seeking a Sr. Extrusion Technician in Santa Clara, California. The role involves operating extruders and improving manufacturing processes according to quality standards. Candidates must have over 5 years of experience in a medical device environment.

This position requires effective communication skills, familiarity with ISO Quality systems, and experience with IQ/OQ Validation. Benefits include healthcare programs and a 401(k) with a company match.

Qualifications

• 5+ years operating extruders in a medical device environment.
• Experience with IQ/OQ Validation.
• Background in a highly regulated industry.

Responsibilities

• Operate and maintain extrusion equipment.
• Ensure compliance with quality standards.
• Collaborate with cross-functional teams on prototypes.
• Train team members on machines and procedures.

Skills

Operating extruders

Communication skills (verbal & written)

Understanding ISO Quality systems

Process training

Problem-solving skills

Education

High School Diploma, GED or equivalent

Job description

Description

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. Extrusion Technician 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. Extrusion Technician 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.

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

• 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 comprehend English
• IQ/OQ Validation experience

The pay range for this role is $42 - 50.00 an hour. 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.

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

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.

Our benefits include 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.