Engineering Manager – Extrusion Engineering & Process Validation

About the role

This position is responsible for building, standardizing, and continuously improving the engineering systems used to develop, characterize, validate, and commercialize medical extrusion processes. Beyond managing engineering projects, this individual will establish the technical framework, methodologies, documentation standards, and validation strategies that ensure products can be consistently transferred into manufacturing while meeting customer, regulatory, and quality requirements.

Responsibilities

• Build and own the engineering system used to develop, characterize, validate, and commercialize extrusion processes across the organization.
• Establish standardized engineering methodologies, documentation, and best practices for product development and process validation.
• Develop engineering metrics that measure project execution, validation quality, technical readiness, and commercialization success.
• Drive continuous improvement of engineering processes to improve speed, consistency, and technical rigor.
• Lead the Extrusion Engineering team in executing development programs from concept through commercial production.
• Develop robust extrusion processes using materials including Pebax®, Nylon, Polyurethane, Polyethylene, fluoropolymers, and other medical-grade polymers.
• Lead process characterization studies utilizing Design of Experiments (DOE), statistical analysis, and engineering fundamentals.
• Design and optimize extrusion tooling to support complex catheter and medical device applications.
• Lead engineering validation activities including Process Characterization, IQ, OQ, PQ, TMV, and process capability studies.
• Ensure engineering deliverables satisfy FDA Quality System Regulations, ISO 13485, customer requirements, and internal quality standards.
• Lead technology transfer activities from development into production while ensuring repeatability, capability, and manufacturing readiness.
• Partner with Commercial Directors to evaluate new business opportunities and provide technical direction during customer engagements.
• Meet directly with customers to present technical capabilities, review development progress, resolve technical challenges, and support commercialization strategies.
• Provide technical input for quotations by estimating development effort, tooling complexity, validation scope, manufacturing readiness, and project timelines.
• Interface with customers during Design for Manufacturability (DFM) discussions to optimize product designs for successful commercialization.
• Partner with Manufacturing, Quality, Program Management, Supply Chain, and Operations to ensure successful product launches.
• Support manufacturing through technical troubleshooting and process optimization when required.
• Mentor engineers and technicians while developing the next generation of technical leaders.
• Foster a culture of technical excellence, accountability, continuous learning, and innovation.

Requirements

• Bachelor's degree in Engineering, Polymer Engineering, Materials Science, or a related technical discipline.
• 8+ years of engineering experience in medical extrusion, catheter manufacturing, or regulated medical device development.
• 3+ years of engineering leadership experience managing technical teams and engineering projects.
• Demonstrated success developing and validating manufacturing processes for regulated medical devices.
• Extensive knowledge of polymer processing, extrusion tooling, downstream equipment, and process optimization.
• Strong understanding of FDA Design Controls, Process Validation, and ISO 13485 requirements.
• Excellent communication and leadership skills with the ability to engage customers and executive leadership.

Preferred Qualifications

• Experience building engineering organizations, systems, and standardized development methodologies.
• Strong background in Process Characterization, Design of Experiments (DOE), Statistical Process Control (SPC), Process Capability, TMV, IQ/OQ/PQ, and Process Validation.
• Experience commercializing catheter, structural heart, vascular, neurovascular, or other minimally invasive medical devices.
• Knowledge of Lean Manufacturing, Six Sigma, and risk management methodologies.
• Experience supporting customer-facing engineering, proposal development, and technical sales.
• Proven success transitioning complex medical device processes from research and development into high-volume manufacturing.

Benefits

• Medical/Dental/Vision Insurance
• Short-Term Disability
• Long-Term Disability
• Life Insurance
• Paid Vacation Days
• Paid Holidays
• 401k