Sr. Extrusion Engineer

Cirtec Medical, Santa Clara, CA, United States

Duration: Full Time

Description

* 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
Must be able to communicate (verbal & written) and comprehend English
IQ/OQ Validation experience

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.
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.