Senior Principal Engineer, Medical Device Innovation

Integra-Lifesciences; Mansfield (MA); Hybrid; USD 167,000 - 229,000; Full time

Job summary

Integra LifeSciences seeks a Senior Principal Engineer to lead development of neurosurgical and fluid-management medical devices. You will drive projects from concept through V&V, regulatory submissions, and manufacturing transfer within FDA 21 CFR Part 820 design controls and ISO 13485, mentoring engineers and coordinating with R&D, Quality, Regulatory, and Manufacturing.

Hybrid work in Mansfield, MA or Princeton, NJ.

Qualifications

• 15+ years in medical device product development under FDA QSR and ISO 13485.
• Proven track record leading complex electromechanical or electro-fluidic devices.
• Experience with design controls, V&V, and regulatory submissions.

Responsibilities

• Lead design and execution of experimental programs within a medical device QMS.
• Plan and execute biocompatibility programs per ISO 10993 with cross-functional teams.
• Architect and validate analog-to-digital data acquisition, signal processing, and testing.
• Develop Python data processing platforms for large multi-format datasets and visualizations.
• Apply DFM to polymer components, injection molding, 3D printing, and adhesives.
• Create GD&T driven 3D models and drawings for manufacturability and inspection.

Skills

Problem solving

Mentorship

Cross-functional collaboration

Technical leadership

Communication

Education

Bachelor’s degree or equivalent

Master’s degree

Ph.D.

Tools

Python

SolidWorks

GD&T

3D CAD

RS-485 / CAN-Bus / Bluetooth

DFM for polymers

CM/EM testing equipment

Job description

Integra LifeSciences seeks a Senior Principal Engineer to lead development of neurosurgical and fluid-management medical devices. You will drive projects from concept through V&V, regulatory submissions, and manufacturing transfer within FDA 21 CFR Part 820 design controls and ISO 13485, mentoring engineers and coordinating with R&D, Quality, Regulatory, and Manufacturing.

Hybrid work in Mansfield, MA or Princeton, NJ.