Biomerics is seeking an Engineering Manager to lead the Extrusion Engineering & Process Validation organization at our Brooklyn Park Center of Excellence in Brooklyn Park, Minnesota. This hands-on leadership role will build, standardize, and continuously improve the engineering systems used to develop, characterize, validate, and commercialize medical extrusion processes. The Engineering Manager will establish the technical framework, documentation standards, and validation strategies that ensure products can be transferred into manufacturing while meeting customer, regulatory, and quality requirements. The role combines technical leadership with people development, actively contributing to complex engineering work, including process development, characterization, validation planning, customer technical discussions, and problem solving for critical programs. Key responsibilities include:
Biomerics is seeking an Engineering Manager to lead the Extrusion Engineering & Process Validation organization at our Brooklyn Park Center of Excellence in Brooklyn Park, Minnesota. This hands-on leadership role will build, standardize, and continuously improve the engineering systems used to develop, characterize, validate, and commercialize medical extrusion processes. The Engineering Manager will establish the technical framework, documentation standards, and validation strategies that ensure products can be transferred into manufacturing while meeting customer, regulatory, and quality requirements. The role combines technical leadership with people development, actively contributing to complex engineering work, including process development, characterization, validation planning, customer technical discussions, and problem solving for critical programs. Key responsibilities include:
- Engineering System Leadership: develop and own the engineering system for extrusion processes; standardize methodologies, documentation, and best practices; support Design Controls, Process Characterization, IQ/OQ/PQ, TMV, and technology transfer; develop metrics; drive continuous improvement. - Technical Leadership: lead the Extrusion Engineering team from concept to production; serve as the technical authority for extrusion process development of single-, dual-, and multi-lumen medical tubing; develop robust extrusion processes with materials such as Pebax, Nylon, Polyurethane, Polyethylene, fluoropolymers, and other medical-grade polymers; conduct DOE studies and statistical analysis;
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- Engineering System Leadership: develop and own the engineering system for extrusion processes; standardize methodologies, documentation, and best practices; support Design Controls, Process Characterization, IQ/OQ/PQ, TMV, and technology transfer; develop metrics; drive continuous improvement. - Technical Leadership: lead the Extrusion Engineering team from concept to production; serve as the technical authority for extrusion process development of single-, dual-, and multi-lumen medical tubing; develop robust extrusion processes with materials such as Pebax, Nylon, Polyurethane, Polyethylene, fluoropolymers, and other medical-grade polymers; conduct DOE studies and statistical analysis;
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Based on: Engineering Manager, Extrusion Engineering & Process Validat
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