Senior Extrusion Engineer - Plymouth, MN

About the role

Serve as the technical owner for extrusion processes at the Nathan Lane site, accountable for both short-term manufacturing performance and long-term process stability.

Define, document, and execute a long-term extrusion stability strategy, including equipment, tooling, materials, process controls, and standard work.

Establish and maintain robust process windows, control plans, and monitoring strategies to ensure consistent output and sustained process capability.

Provide direct shop-floor engineering support to troubleshoot and resolve complex extrusion process issues related to materials, tooling, equipment, and process parameters.

Lead process validations and revalidations (IQ/OQ/PQ) in support of sustaining operations, capacity expansion, and process changes.

Drive continuous improvement initiatives focused on yield, scrap reduction, OEE, and cost optimization, with emphasis on preventing recurrence of chronic issues.

Partner with Production, Maintenance, and Quality to improve equipment reliability, preventive maintenance strategies, and process robustness.

Lead technical risk assessments and proactively address aging equipment, supplier variability, and material obsolescence risks.

Support change management activities, ensuring changes align with the long-term extrusion strategy and quality system requirements.

Develop and maintain manufacturing documentation, including process specifications, control plans, and work instructions.

Support quality investigations and CAPAs by performing deep technical root cause analysis and implementing sustainable corrective actions.

Act as the extrusion subject matter expert for the site, mentoring engineers and technicians and elevating overall technical capability.

Responsibilities

• Serve as the technical owner for extrusion processes at the Nathan Lane site, accountable for both short-term manufacturing performance and long-term process stability.
• Define, document, and execute a long-term extrusion stability strategy, including equipment, tooling, materials, process controls, and standard work.
• Establish and maintain robust process windows, control plans, and monitoring strategies to ensure consistent output and sustained process capability.
• Provide direct shop-floor engineering support to troubleshoot and resolve complex extrusion process issues related to materials, tooling, equipment, and process parameters.
• Lead process validations and revalidations (IQ/OQ/PQ) in support of sustaining operations, capacity expansion, and process changes.
• Drive continuous improvement initiatives focused on yield, scrap reduction, OEE, and cost optimization, with emphasis on preventing recurrence of chronic issues.
• Partner with Production, Maintenance, and Quality to improve equipment reliability, preventive maintenance strategies, and process robustness.
• Lead technical risk assessments and proactively address aging equipment, supplier variability, and material obsolescence risks.
• Support change management activities, ensuring changes align with the long-term extrusion strategy and quality system requirements.
• Develop and maintain manufacturing documentation, including process specifications, control plans, and work instructions.
• Support quality investigations and CAPAs by performing deep technical root cause analysis and implementing sustainable corrective actions.
• Act as the extrusion subject matter expert for the site, mentoring engineers and technicians and elevating overall technical capability.

Requirements

• Bachelor's degree with a minimum of 4 years of relevant experience
• Master's degree with a minimum of 2 years relevant experience
• PhD with 0 years relevant experience

Qualifications

• Experience with medical-grade polymer extrusion, such as multi-lumen or tight-tolerance tubing
• Background working in a regulated manufacturing environment (FDA, ISO 13485, GMP)
• Proficiency with SPC, process characterization, DOE, and data-driven process optimization
• Experience leading continuous improvement initiatives (Lean, Six Sigma, scrap/yield reduction)
• Demonstrated ability to act as a technical mentor or extrusion SME for engineers and technicians
• Experience with extrusion equipment lifecycle management, including upgrades or obsolescence planning
• Familiarity with supplier qualification and technical collaboration for materials, tooling, or equipment

Skills

• Technical expertise in medical-grade polymer extrusion
• Experience in a regulated manufacturing environment
• Proficiency in statistical process control (SPC), process characterization, design of experiments (DOE), and data-driven process optimization
• Leadership in continuous improvement initiatives
• Ability to mentor and develop technical capabilities
• Experience with extrusion equipment lifecycle management
• Knowledge of supplier qualification and technical collaboration

Benefits

Salary ranges for U.S. (excl. PR) locations (USD): $102,400.00 - $153,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.

Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Regular employees are those who are not temporary, such as interns.

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic Benefits And Compensation Plans