Engineering Manager – Extrusion Engineering & Process Validation

Engineering Manager – Extrusion Engineering & Process Validation

Biomerics is seeking an experienced and technically accomplished Engineering Manager – Extrusion Engineering & Process Validation to lead the Extrusion Engineering organization at our Brooklyn Park Center of Excellence.

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.

The Engineering Manager is a hands-on working manager who leads the Extrusion Engineering team while actively contributing to technical execution. In addition to coaching and developing engineers, this individual will personally lead complex engineering efforts, including process development, characterization, validation strategy, customer technical discussions, and problem-solving for critical programs.

This role is responsible for developing robust extrusion processes for new medical devices, creating scalable manufacturing solutions, and leading engineering validation activities, including process characterization, IQ/OQ/PQ, TMV, and design verification. Serving as the technical authority for extrusion process development, the Engineering Manager partners closely with Commercial, Quality, Manufacturing, Program Management, and customers to successfully develop, validate, commercialize, and transfer products into manufacturing throughout the product development lifecycle.

The ideal candidate combines deep technical expertise in medical extrusion with the leadership skills necessary to build high-performing engineering systems, mentor engineers, and drive operational excellence.

• Develop 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.
• Build and maintain engineering procedures supporting Design Controls, Process Characterization, IQ/OQ/PQ, TMV, and technology transfer activities.
• 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.
• Serve as the technical authority for extrusion process development involving single-, dual-, and multi-lumen medical tubing.
• 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.
• Develop scientifically sound process windows that establish robust manufacturing conditions.
• 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…