Senior Extrusion Engineer

Dahl Consulting; Santa Clara (CA); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401k with company match

Paid time off

Job summary

Dahl Consulting partners with a leading medical device manufacturer in Santa Clara, CA to identify a Senior Extrusion Engineer. This onsite role leads extrusion operations, collaborates with cross-functional teams, and drives process improvements for high-precision tubing products.

The successful candidate will oversee tooling, process development, IQ/OQ validations, and manufacturing transfer activities, ensuring quality, efficiency, and regulatory compliance in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related field; or equivalent.
• Minimum of 5 years of extrusion engineering experience.
• Direct experience in medical device or regulated manufacturing environments.
• Experience with medical tubing extrusion and thermoplastic extrusion.
• Experience developing or supporting single-lumen and multi-lumen tubing extrusion.
• Strong knowledge of extrusion tooling, process development, equipment setup, and machine maintenance.
• IQ/OQ validations and process qualification experience.
• Familiarity with ISO quality systems and manufacturing best practices.
• Strong troubleshooting and root-cause analysis skills.
• Ability to read and communicate in English.

Responsibilities

• Provide technical leadership for extrusion manufacturing operations.
• Manage project schedules, priorities, and engineering deliverables for extrusion processes.
• Serve as primary engineering resource and SME for onsite extrusion operations.
• Support technicians and production personnel by troubleshooting process/equipment issues.
• Act as key customer-facing and internal stakeholder interface for extrusion projects.
• Spend substantial time on the production floor supporting manufacturing operations.
• Read and interpret product specs to determine machine setups and material needs.
• Adjust tooling and process parameters within approved specs to ensure quality.
• Evaluate extrusion equipment performance and identify improvement opportunities.
• Lead or support root cause investigations and CAPA implementations.
• Train operators and technicians on extrusion processes, equipment, and procedures.

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

Extrusion tooling and equipment

Job description

Title: Senior Extrusion Engineer

Location: Santa Clara, CA

Job Type: Permanent/Direct-Hire

Compensation: $100,000 - $150,000 + bonus (annually)

Industry: Medical Device Manufacturing

About The Role

Our recruiting firm is partnering with a leading medical device manufacturing organization to identify a Senior Extrusion Engineer. This company specializes in the development and manufacture of high-precision components used in minimally invasive medical devices, catheter-based systems, and other regulated healthcare applications.

This is a hands-on engineering position that will serve as the site's primary extrusion subject matter expert. The successful candidate will provide technical leadership for extrusion operations, support production teams, interact directly with customers, and help drive process improvements, quality, and manufacturing performance. This position is based onsite and is not eligible for remote work.

Job Description

The Senior Extrusion Engineer will be responsible for the technical oversight and continuous improvement of medical tubing extrusion processes. This role requires close collaboration with operations, technicians, customers, suppliers, and cross-functional teams to support both existing production and new product development activities.

Responsibilities

• Provide technical leadership for extrusion manufacturing operations.
• Manage project schedules, priorities, and engineering deliverables related to extrusion processes.
• Serve as the primary engineering resource and technical expert for onsite extrusion operations.
• Support technicians and production personnel by troubleshooting process and equipment-related issues.
• Act as a key customer-facing and internal stakeholder interface for extrusion projects.
• Spend substantial time on the production floor supporting manufacturing operations.
• Read and interpret product specifications to determine machine setup requirements and material needs.
• Adjust tooling and process parameters within approved specifications to ensure product quality and process stability.
• Evaluate extrusion equipment performance and identify opportunities to improve productivity, efficiency, and quality.
• Monitor equipment operation and investigate product defects, process deviations, and equipment malfunctions.
• Collaborate with customers and internal teams on product specifications, prototype development, and manufacturing transfer activities.
• Coordinate with vendors regarding raw materials, tooling, and extrusion equipment.
• Lead or support root cause investigations and implementation of corrective and preventive actions.
• Develop and evaluate alternative manufacturing methods and process improvements.
• Perform process validations, including IQ/OQ activities.
• Train operators, technicians, and other team members on extrusion processes, equipment, and procedures.
• Maintain engineering documentation and support change control activities.
• Ensure compliance with quality systems, safety requirements, FDA regulations, and other applicable regulatory standards.

Qualifications

Required

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related engineering discipline, or an equivalent combination of education and experience.
• Minimum of 5 years of extrusion engineering experience.
• Direct experience within the medical device industry or another highly regulated manufacturing environment.
• Experience with medical technology extrusion processes.
• Experience extruding medical tubing.
• Experience with thermoplastic extrusion processes.
• Experience developing or supporting single-lumen and multi-lumen tubing extrusion.
• Demonstrated expertise in extrusion tooling, process development, equipment setup, and machine maintenance.
• Experience supporting manufacturing operations in an onsite production environment.
• Experience performing IQ/OQ validations and process qualification activities.
• Knowledge of ISO quality systems and manufacturing best practices.
• Strong troubleshooting, root cause analysis, and process optimization skills.
• Ability to communicate effectively with customers, suppliers, operators, technicians, and cross-functional teams.
• Ability to read, write, and communicate effectively in English.

Preferred

• Experience serving as the lead extrusion engineer or primary technical SME within a manufacturing site.
• Experience supporting new product introductions, prototype builds, and commercialization activities.
• Experience with catheter, minimally invasive, or other medical tubing applications.
• Experience working directly with customers on technical and manufacturing projects.
• Familiarity with FDA-regulated manufacturing environments.
• Experience implementing continuous improvement initiatives that improve quality, efficiency, or throughput.
• Prior experience training and mentoring technical or production personnel.

Work Environment

• Onsite position.
• Regular interaction with extrusion technicians, operators, engineering teams, suppliers, and customers.
• Significant time spent on the manufacturing floor supporting operations and process execution.
• No direct reports; however, the role provides technical leadership and guidance across the extrusion function.

Benefits

Our partner offers a comprehensive benefits package that includes insurance (medical, dental, vision, & life), 401k + company match, paid time off, and tuition reimbursement.

Equal Opportunity Statement

As an equal opportunity employer, Dahl Consulting welcomes candidates of all backgrounds and experiences to apply. If this position sounds like the right opportunity for you, we encourage you to take the next step and connect with us. We look forward to meeting you!