Head of Systems Engineering, Medical Devices (Hybrid/Remote)

K-Recruiting Life Sciences; Houston (TX); Hybrid; USD 120,000 - 170,000; Full time

Job summary

LivaNova seeks a Senior Systems Engineer to lead systems engineering, risk management and design control across medical device programs. You will guide cross-functional teams to decompose design inputs, develop verification/validation strategies and ensure regulatory compliance.

The role emphasizes mentoring, collaboration with stakeholders, and maintaining rigorous traceability and documentation in a regulated environment.

Qualifications

• Experience with design controls for medical devices per ISO 13485 and 21 CFR 820.30.
• Expert in systems engineering (INCOSE/MBSE).
• Strong risk management and traceability practices.

Responsibilities

• Lead systems engineering, risk management and design control in collaboration with stakeholders.
• Mentor and develop Systems Engineering team for career growth.
• Collaborate with cross-functional teams to meet project objectives.
• Define and decompose design inputs into systems and interfaces for design, verification and validation.
• Develop risk assessments and risk control measures; manage traceability matrices.

Skills

Systems Engineering

Leadership

Technical writing

Communication

English

Regulatory knowledge

Project management

Education

BS in Engineering

INCOSE certification

MS preferred

Tools

MBSE tools

Regulatory documentation tools

Job description

LivaNova seeks a Senior Systems Engineer to lead systems engineering, risk management and design control across medical device programs. You will guide cross-functional teams to decompose design inputs, develop verification/validation strategies and ensure regulatory compliance.

The role emphasizes mentoring, collaboration with stakeholders, and maintaining rigorous traceability and documentation in a regulated environment.