Principal Quality Engineer, Advanced Catheters & Extrusions

You will make an impact by:

• Serve as a Quality Engineering technical subject matter expert for Advanced Catheters and Extrusions programs, providing technical guidance throughout new product development, new product introduction, pilot manufacturing, and commercialization.
• Lead Quality Engineering activities supporting the development and validation of products, manufacturing processes, equipment, and test methods, including Test Method Validation (TMV) and IQ/OQ/PQ activities.
• Apply a data-driven and statistical approach to Quality Engineering decisions, including capability studies, data analysis, experimental results, and assessment of process and product performance.
• Provide Quality Engineering expertise for extrusion, polymer, catheter, and balloon-related technologies, including evaluation of material properties, design requirements, tolerances, specifications, and associated product and manufacturing risks.
• Partner cross-functionally with R&D, Process Engineering, Manufacturing, Operations, Supplier Quality, and other Quality teams to develop robust products and manufacturing processes and support successful program execution.
• Collaborate across sites and with technical centers of excellence to support manufacturing readiness, validation, technology transfer, and commercialization activities.
• Develop, review, and approve technical documentation including validation protocols and reports, specifications, test methods, risk-management documentation, process controls, and change-control documentation.
• Lead and provide technical guidance for complex product, process, and Quality investigations, including nonconformances, CAPA, supplier quality issues, and other Quality or compliance matters.
• Provide technical mentorship and guidance to engineers and technicians, helping build Quality Engineering capability and consistency across programs.
• Other incidental duties

What you'll need (Required):

• Bachelor's degree in engineering or scientific related fields with a minimum of 6 years of experience in Quality Engineering, Manufacturing Quality, Process Engineering, or a related engineering discipline; OR Master's degree in engineering or scientific related fields with a minimum of 5 years of experience in these areas.
• Demonstrated experience with Test Method Validation (TMV) and process/equipment validation, including IQ/OQ/PQ.
• Highly regulated industry experience.

What else we look for (Preferred):

• Medical device industry experience supporting Class II and/or Class III products.
• Experience with extrusion and/or polymer manufacturing processes, including material property testing and analysis.
• Experience supporting catheters, balloon, extrusion, or other polymer-based medical-device technologies.
• Experience with technology transfer and supporting products or manufacturing processes from development through pilot production, validation, manufacturing readiness, and commercialization.
• Knowledge of or experience with Product Development Process (PDP), Design Controls, and risk management.
• Experience with material- and design-related characterization, including an understanding of specifications and tolerancing.
• Experience leading cross-functional technical teams or projects and partnering effectively across multiple sites.
• Project management experience supporting complex product development or manufacturing programs.
• Experience applying statistical methods to capability studies, validation activities, and technical decision-making.
• Experience providing Quality Engineering support within a development, pilot manufacturing, laboratory, or Center of Excellence environment.
• Certified Quality Engineer (CQE), Six Sigma Black Belt, Lean Black Belt, or related certification.