Ingeniero sénior de calidad

## Ingénieur qualité sr Postuler:
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):
R74439

We anticipate the application window for this opening will close on - 30 Oct 2026

Chez 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.

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* 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.
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* 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 changes

Other 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…