Sr Principal Engineer - Software Quality (Medical Devices)

Location: Gloucester, Gloucestershire, United Kingdom

Company

Medical technology company developing healthcare products and digital solutions to help save and sustain lives.

What you will do

• Lead software quality programs aligned with Product Lifecycle Management, Change Control Management, design controls, and quality system regulations.
• Translate Agile software development practices into compliant frameworks covering traceability, documentation, verification, and validation.
• Implement software design controls for requirements, architecture, risk management, cybersecurity risk, configuration management, and change management.
• Integrate Quality Management System processes into software workflows, including CAPA, nonconformance handling, complaint feedback, audit readiness, and inspection support.
• Support EU MDR compliance through technical documentation, regulatory impact assessments, post-market surveillance inputs, and software lifecycle evidence.
• Guide enterprise standards for software quality, cybersecurity, reliability engineering, data analytics, and lifecycle management while collaborating with Quality, Regulatory Affairs, R&D, Product Management, Cybersecurity, Clinical, and Manufacturing teams.

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related discipline.
• 10+ years of progressive experience in software quality engineering, including regulated medical device software and/or digital health platforms.
• Strong expertise in ISO 13485 Quality Management Systems, EU MDR, IEC 62304, and FDA software and quality system expectations.
• Experience integrating Agile development with regulatory compliance, traceability, documentation, and change management.
• Understanding of software architecture, system integration, cloud systems, cybersecurity, data privacy, software risk management, hazard analysis, and vulnerability management.
• Strong technical leadership, problem-solving, analytical, and decision-making skills.

Nice to have

• Master’s degree or PhD.
• Experience with IEC 82304 where applicable.

Culture & Benefits

• Mission-driven work focused on saving and sustaining lives.
• Culture built around courage, trust, collaboration, ownership, and accountability.
• Equal employment opportunity and reasonable accommodation support.