Sr. Extrusion Technician

MedStar Health; Santa Clara (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device manufacturer is seeking a Sr. Technician for their Extrusion team in Santa Clara. This role involves operating extruders, improving manufacturing processes, and ensuring product quality in a regulated environment. Candidates should have over 5 years of relevant experience and a background in medical device manufacturing. The position offers competitive hourly pay and a commitment to a respectful and innovative work culture.

Benefits

Healthcare and well-being programs

Paid Time Off

401(k) retirement savings with company match

Training and career development

Qualifications

• 5+ years operating extruders in a medical device environment.
• Experience with ISO Quality systems and World Class Manufacturing principles.
• IQ/OQ Validation experience.

Responsibilities

• Operate extruders and downstream equipment safely.
• Develop and improve processes to meet specifications.
• Inspect products and maintain quality standards.

Skills

Operating extruders

Communication (verbal & written)

ISO Quality systems

Process control

Maintenance

Education

High School Diploma, GED or equivalent

Job description

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:

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.

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 everyone 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 its related companies fully endorse equal opportunity. 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 an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. 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.