Sr Principal Engineer, Product Development

Integra LifeSciences seeks a Senior Principal Engineer to lead medical device development for neurosurgical and critical care applications. The role combines hands-on technical expertise in electromechanical systems, signal processing, and polymer design with mentorship responsibilities across R&D, from feasibility through regulatory submission and manufacturing.

Responsibilities

• Lead experimental design and execution across design verification, validation, and regulatory compliance within FDA and ISO frameworks
• Plan and execute biocompatibility evaluation programs per ISO 10993 in collaboration with toxicologists and regulatory partners
• Design, prototype, and validate data acquisition systems with error analysis, filtering, and advanced signal processing
• Develop Python-based data processing platforms for algorithm prototyping, dataset analysis, and technical visualization
• Apply Design for Manufacturability principles to polymeric components and mentor junior engineers on design standards and best practices

Requirements

• Bachelor's degree with 15+ years experience, or Master's with 12+, or Ph.D. with 10+ in mechanical, systems, or electrical engineering
• 10+ years progressive medical device development under FDA 21 CFR Part 820 and ISO 13485 standards
• Proven expertise in analog-to-digital data acquisition systems, signal conditioning, filtering, and sensor integration
• Strong Python proficiency for scientific computing, algorithm prototyping, and multi-format dataset analysis
• Hands-on embedded systems and automated test equipment experience with microcontrollers and industrial communication protocols
• Design for Manufacturability background in medical-grade polymers: injection molding, additive manufacturing, CNC machining, adhesives
• Expert-level SolidWorks CAD modeling and GD&T-compliant 2D drawing creation; knowledge of biofluid mechanics