Sr Principal Engineer, Product Development

Integra LifeSciences · Facility, MA +2 more

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Medical DeviceFull-time$167k–$229kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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