Ingeniero sénior de calidad

Medtronic plc; Lafayette, Minneapolis (CO, MN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Onsite four days a week

Job summary

Medtronic plc is seeking a Senior Risk Management Quality Engineer to join the surgical operating unit within the new product development quality team. The role focuses on risk management, design controls, and regulatory compliance across the medical device lifecycle.

The ideal candidate will have proven expertise in DFMEA, failure mode analysis, and post-market surveillance, ensuring patient safety remains central to development efforts. On-site collaboration is required.

Qualifications

• Experience with FDA regulations, ISO 13485, ISO 14971, and related standards.
• Ability to lead risk management activities across product lifecycle in a medical device setting.
• Proven skills in hazard analysis, DFMEA, and risk-based decision making.

Responsibilities

• Develop and maintain risk management plans, files, and reports with regular reviews.
• Lead DFMEA and analyze risks to implement effective controls and actions.
• Coordinate with cross-functional teams to ensure patient safety and design control compliance.
• Oversee post-market surveillance and regulatory audits as needed.

Skills

Risk management

DFMEA

Regulatory compliance

FDA regulations

ISO 13485

Design controls

Root cause analysis

Leadership

Education

Bachelor's degree in engineering or related technical field

Job description

## Ingénieur qualité srPostuler: Sur site: Lafayette, Colorado, United States of America: Minneapolis, Minnesota, United States of America: Temps plein: Offre publiée hier: Date de fin : 30 octobre 2026 (Il reste 5 jour(s) pour postuler): R74439We anticipate the application window for this opening will close on - 30 Oct 2026Chez 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 Senior Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle. **Job Description:**Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.**Key Responsibilities:**Develop and maintain comprehensive strategies for risk management activities, including:* Collaborating cross-functionally to ensure the utmost product quality for patient safety* Creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews.* Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures.* Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.* Analyzing and reviewing product complaints to anticipate and prevent future issues.* Integrating product security measures to protect against potential vulnerabilities into the risk management file.* Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file.* Leading design review and maintaining the risk management file throughout the product lifecycle* Developing and managing post-market surveillance plans to monitor product performance and safety in the field.* Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch.* Ensuring traceability between risk management file, requirements and design outputs utilizing a requirements management tool* Evaluate the safety risk implications of design changesOther potential responsibilities* Lead and mentor teams in the development, implementation, and maintenance of the quality system processes and standards.* Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product quality and compliance throughout the product lifecycle.* Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.* Oversee design validation and design verification activities of user needs and design inputs, including the development of test plans, protocols, test methods and reports.* Ensure thorough and accurate documentation including test results, risk assessments, and reports.**Qualifications:****Minimum Requirements:*** **Education:** Minimum bachelor’s degree in engineering, or a related technical field. Advanced degree is preferred* **Regulatory Knowledge:** In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.* **Problem-Solving:** Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.* **Communication:** Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.* **Leadership:** Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.**Preferred Qualifications:*** **Certifications:** Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.* **Experience:** Regulated engineering field* **Industry Experience:** Medical device industry.* **Technical Skills:** Proficient in quality management systems, risk management, regulatory compliance, and statistics.* **Other:** Basic knowledge of human anatomy/physiology and surgical proceduresAt Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 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.Pour les diplômes de baccalauréat obtenus en dehors des États-Unis, un diplôme qui satisfait aux exigences de la réglementation 8 C.F.R. § 214.2 (h) (4) (iii) (A) est requis.**Exigences physiques du poste**Les 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.Les exigences physiques décrites dans la section Responsabilités de cette fiche de poste sont représentatives de celles auxquelles un employé doit satisfaire pour remplir correctement les fonctions essentielles du poste. Des ajustements raisonnables peuvent être apportés pour permettre aux personnes en situation de handicap de remplir ces fonctions essentielles. Rôles administratifs : dans l’exercice de ses fonctions, l’employé est régulièrement appelé à se déplacer de façon autonome. Il est également amené à utiliser un ordinateur et à communiquer avec ses pairs et ses collègues. Contactez votre responsable ou votre service RH local pour connaître les conditions de travail et les exigences physiques spécifiques à chaque rôle.**Autorisation de travail et parrainage** Chez Medtronic, nous nous engageons à favoriser un environnement dans lequel les employés peuvent s'épanouir et avoir un impact significatif. Conformément à notre approche de planification de la main-d'œuvre à l'échelle de l'entreprise, le parrainage d'autorisation de travail aux États-Unis (H-1B, TN, J, etc.) est proposé exclusivement pour les postes de niveau Principal et supérieur, où l'expertise spécialisée s'aligne sur les besoins métier à long terme. Les postes en dessous du niveau Principal exigent que les candidats possèdent une autorisation de travail américaine sans restriction au moment de l'embauche et pour la durée de l'emploi. Rejoignez-nous et aidez-nous à accomplir notre mission, à savoir soulager la douleur, rétablir la santé et prolonger la vie, en valorisant votre expérience et votre perspective uniques.