Senior Software Quality Engineer

About the role

Medtronic, a global leader in healthcare technology, is looking for a highly skilled and experienced Senior Software Quality Engineer to join its new product development quality team in the surgical operating unit. The role supports software quality activities across the product development lifecycle so that products are safe, effective, reliable and compliant with applicable standards and internal procedures, working closely with software engineering, systems engineering, regulatory and quality teams.

Key responsibilities

• Support software quality activities from requirements and design through verification, validation, release and post-market support.
• Collaborate with project and development teams to ensure compliance with company procedures, standards and regulatory requirements.
• Give early quality input on requirements, architecture, algorithms, code and technical design reviews.
• Review requirements, design outputs, test cases/results and traceability documentation for completeness, clarity and compliance.
• Support risk management activities such as SFMEA, hazard analysis, risk mitigation and verification.
• Support verification and validation planning, execution, documentation, defect investigations, root cause analysis and CAPA activities.
• Contribute to software configuration management, change control, release readiness and documentation consistency.
• Support internal and external audits and regulatory readiness while monitoring software quality metrics and driving process improvements.
• Provide quality input on reliability, cybersecurity, usability and other software quality considerations.

Required profile

• Bachelor's degree in Engineering, Computer Science, Software Engineering, Science or a related technical field.
• Experience in software quality, software development, verification and validation or a related engineering/quality role.
• Strong analytical, documentation and problem-solving skills, and effective communication across functions and levels.
• Ability to manage multiple priorities and deliver work on time.
• Minimum of 3-4 days per week onsite.

Required skills

• Working knowledge of the software development lifecycle.
• Understanding of design controls, requirements traceability, verification and validation and risk management.
• Preferred: experience in medical device or regulated product development, familiarity with ISO 13485, ISO 14971, IEC 62304, 21 CFR 820 and IEC 60601-1, Agile, embedded or medical device software, cybersecurity evaluation knowledge, and audit or regulatory submission support.

What we offer

• Salary range in the United Kingdom of 76,800 to 115,200 GBP, depending on experience, skills and qualifications.
• Eligibility for the Medtronic Incentive Plan (MIP).
• A wide range of benefits and resources.