Senior Principal Engineer, Med Devices - Lead & Innovate

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

Job summary

Integra LifeSciences is seeking a Senior Principal Engineer to lead advanced neurosurgical, critical care, and fluid‑management device development. You will guide projects from feasibility through V&V, regulatory submission, and manufacturing transfer while mentoring engineers.

The role requires hands‑on depth in electromechanical design, sensor integration, embedded systems, and polymer device manufacturing, with strong communication across R&D, Quality, and Regulatory teams.

Qualifications

• 15+ years of experience in mechanical, systems, electrical engineering or closely related field.
• 10+ years of progressive medical device development under FDA QSR and ISO 13485.
• Proven expertise in analog‑to‑digital data acquisition systems and signal processing.

Responsibilities

• Lead experimental programs within a medical device QMS, guiding design verification and validation per 21 CFR Part 820 and ISO 13485.
• Coordinate biocompatibility evaluation programs per ISO 10993 with toxicologists and regulatory partners.
• Architect and validate data acquisition systems and develop signal‑processing algorithms.
• Develop Python data processing platforms and visualize big datasets for decision making.
• Apply DFM to polymer devices, including injection molding and additive manufacturing.
• Create and maintain GD&T compliant 3D/2D drawings and robust designs.
• Synthesize technical data for design reviews and regulatory discussions.
• Mentor junior engineers and contribute to design standards and continuous improvement.
• Support DHF, ISO 14971 risk management, change control, and regulatory interactions.

Skills

Python for scientific computing

Embedded systems development

3D CAD modeling (SolidWorks)

GD&T and engineering drawings

Data acquisition and signal processing

Bio-fluid mechanics knowledge

Design for Manufacturability (DFM)

Communication for cross-functional..

Regulatory knowledge (FDA 21 CFR 820/

Education

Bachelor’s degree or equivalent (Mechanical/Systems/Electrical)

Master’s degree

Ph.D. in a related technical discipline

Tools

SolidWorks

Python

RS-485 / CAN-Bus / Bluetooth (embedded)

Automated test equipment

Job description

Integra LifeSciences is seeking a Senior Principal Engineer to lead advanced neurosurgical, critical care, and fluid‑management device development. You will guide projects from feasibility through V&V, regulatory submission, and manufacturing transfer while mentoring engineers.

The role requires hands‑on depth in electromechanical design, sensor integration, embedded systems, and polymer device manufacturing, with strong communication across R&D, Quality, and Regulatory teams.