Cirtec Medical · 2 weeks ago
Sr. Extrusion Engineer
Santa Clara, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $150K/yr
5+ years expCirtec Medical is a leading provider of manufacturing solutions for complex Class II and III medical devices. They are seeking a Senior Mechanical Engineer to lead product development teams in bringing complex medical device designs from concept to market, ensuring adherence to quality and safety standards throughout the manufacturing process.
ManufacturingMedical Device
No H1B
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
Qualification
Required
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
Benefits
Training and career development
Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off
401(k) retirement savings with a company match
Company
Cirtec Medical
Stellar Technologies is manufacturer of precision components and assemblies.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2016-08-01Acquired
Leadership Team
Ed Philbin
Chief Financial Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
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