Design Software Quality Consultant (Medical Devices)

Key Responsibilities

• Review and assess Design History Files (DHFs) and product development documentation for acquired medical device products.
• Support software design quality activities during post-acquisition product integration.
• Ensure compliance with internal quality standards and global regulatory requirements.
• Lead Model-Based Systems Engineering (MBSE) activities for software-enabled medical devices.
• Review software engineering deliverables to ensure compliance with design controls and quality requirements.
• Partner with cross-functional teams including R&D, Software Engineering, Quality, and Regulatory Affairs.
• Support risk management, usability engineering, and software lifecycle compliance activities.

Required Qualifications

• 10+ years of Software Quality Engineering experience in the medical device industry.
• Strong experience with Software Design Quality and Design Controls.
• Hands-on experience with Model-Based Systems Engineering (MBSE).
• Experience supporting software quality for new product development or medical device integration/remediation projects.
• Knowledge of IEC 62304, IEC 60601, ISO 14971, and medical device software regulations.
• Experience with Software as a Medical Device (SaMD).
• Strong understanding of software verification, validation, and compliance within regulated environments.

Pay

TBD

Schedule

Remote work

Benefits

Flexible remote work schedule