Ingénieur sr Qualité logicielle

Medtronic plc; Greater London; Hybrid; GBP 77,000 - 115,000; Full time

Benefits offered by this job

Flexible benefits

Job summary

Medtronic plc in London is seeking a highly skilled Software Quality Engineer to join the surgical operating unit within the new product development quality team.

You will support software quality activities across the product lifecycle, collaborating with software, systems, regulatory, and quality teams to drive design quality, risk management, verification and validation, documentation quality, and continuous improvement. In-person onsite 3–4 days a week.

Qualifications

• 3–7 years of experience in software quality, development, verification and validation, or related engineering/quality roles.
• Familiarity with design controls, requirements traceability, verification & validation, and risk management.
• Experience in medical device or regulated product development environments is preferred.
• Knowledge of ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, IEC 60601-1.
• Familiarity with Agile methodologies and embedded software or medical device software.

Responsibilities

• Support software quality activities across the full lifecycle from requirements to post-market support.
• Collaborate with project and development teams to ensure compliance with procedures, standards, and regulatory requirements.
• Provide early quality input on requirements, architecture, algorithms, code, and design reviews.
• Review requirements, design, test cases, and traceability documentation for completeness and compliance.
• Support risk management activities including SFMEA, hazard analysis, risk mitigation, and verification/validation.
• Contribute to verification/validation planning, execution, documentation, defect investigations, root cause analysis and CAPA.
• Support software configuration management, change control, release readiness, and documentation consistency.
• Assist audits and regulatory submissions; monitor software quality metrics and drive improvements.

Skills

Software lifecycle

Design controls

Traceability

Risk management

Analytical skills

Documentation

Communication

Multi-priority management

Education

Bachelor’s degree in Engineering, Computer Science, Software Engineering, Science, or related field

Job description

## Ingénieur sr Qualité logiciellePostuler: Sur site: London, London, United Kingdom: Temps plein: Offre publiée aujourd'hui: R76999Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.**Journée type** 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** * 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. **Required Qualifications** * 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. **Preferred Qualifications** * 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. 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.Exigences physiques du posteLes déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.**Alerte de fraude au recrutement** Nous avons pris connaissance de l’existence d’arnaques de type phishing visant les personnes à la recherche d’un emploi. Veuillez garder les points suivants à l’esprit : Postulez uniquement via les canaux officiels de Medtronic. Toutes les communications légitimes de recrutement de Medtronic proviennent de plateformes Medtronic approuvées et d’adresses e-mail officielles se terminant par @medtronic.com. Medtronic ne demande jamais de paiement ni d’informations personnelles sensibles (telles que des coordonnées bancaires ou des informations de sécurité sociale) au cours des premières étapes du processus de recrutement. Toute demande de ce type n’est pas légitime. Si vous recevez un message suspect prétendant provenir de Medtronic, n’y répondez pas, ne cliquez sur aucun lien et n’ouvrez aucune pièce jointe. Si vous avez des questions ou des préoccupations concernant l’authenticité d’une communication prétendument faite par ou au nom de Medtronic, veuillez nous contacter immédiatement à l’adresse [e-mail].**Avantages sociaux et rémunération****Medtronic offre un salaire compétitif et un ensemble d’avantages sociaux flexibles** Le cœur de nos valeurs est animé par un engagement envers nos employés. Nous saluons leurs contributions et partageons avec eux le succès qu’ils ont contribué à créer. Nous offrons un large éventail d’avantages, de ressources et de régimes de rémunération concurrentiels conçus pour vous soutenir à chaque étape de votre carrière et de votre vie personnelle.Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: United Kingdom: 76,800.00 GBP - 115,200.00 GBP |This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).