Senior Software Quality Engineer

Overview

• Support software quality activities across the full lifecycle, from requirements and design through verification, validation, release, and post-market support.
• Collaborate with project and development teams to ensure compliance with company procedures, applicable standards, and regulatory requirements.
• Provide early quality input on software requirements, architecture, algorithms, code, and technical design reviews.
• Review requirements, design outputs, test cases/results, and traceability documentation for completeness, clarity, and compliance.
• Support software risk management activities, including 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/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 throughout development.
• Bachelor’s degree in Engineering, Computer Science, Software Engineering, Science, or a related technical field.
• 3 to 7 years of experience in software quality, software development, verification and validation, or a related engineering/quality role.
• Working knowledge of software development lifecycle activities.
• Understanding of design controls, requirements traceability, verification and validation, and risk management.
• Strong analytical, documentation, and problem-solving skills.
• Effective communication skills and ability to work across multiple functions and organizational levels.
• Ability to manage multiple priorities and deliver work on time.
• Experience in medical device or other regulated product development environments.
• Familiarity with standards and regulations such as ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, and IEC 60601-1.
• Knowledge of Agile development methodology.
• Experience with embedded software, mobile applications, or medical device software.
• Familiarity with cybersecurity evaluations and how threats can translate to patient safety risks.
• Experience supporting audits, inspections, or regulatory submissions.

Bei Medtronic kannst Du eine Karriere für Dein Leben starten. Und Dich für ein gerechtes und innovatives Gesundheitswesen einsetzen, das für alle zugänglich ist. Du wirst zielstrebig Barrieren abbauen, die Innovationen in einer stärker vernetzten und solidarischen Welt im Wege stehen.

Ein Tag im Leben

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Software Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team.

The Software Quality Engineer is responsible for supporting software quality activities throughout the product development lifecycle to ensure products are safe, effective, reliable, and compliant with applicable standards and internal procedures. This role works closely with software engineering, systems engineering, regulatory, and quality teams to drive design quality, risk management, verification and validation, documentation quality, and continuous improvement.

Primary Responsibilities

Required Qualifications

Preferred Qualifications

In-person exchanges are invaluable to our work. We’re working a minimum of 3-4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Physische Jobanforderungen

Die obigen Aussagen sollen die allgemeine Art und den Umfang der Tätigkeit beschreiben, die von den Mitarbeitern in der jeweiligen Position ausgeführt wird. Sie enthalten jedoch nicht alle für diese Position erforderlichen Verantwortlichkeiten und Fähigkeiten.

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