Ingénieur Qualité I

Medtronic plc; Connecticut; On-site; USD 66,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Tuition assistance

Job summary

Medtronic plc is seeking a Risk Management Quality Engineer to join the surgical operating unit within the new product development quality team. The role is onsite 4 days per week and can be based in North Haven, CT; Boston, MA; or Lafayette, CO.

You will lead risk management activities, ensure regulatory compliance, and maintain the risk management file throughout the product lifecycle to safeguard patient safety.

Qualifications

• Bachelor's degree in engineering or related technical field.
• Experience in medical devices, pharmaceuticals, or combination products preferred.
• Familiarity with medical device risk management standards (ISO 14971 concepts).
• Experience with Minitab or other statistical analysis software; CQE/DFMEA design control knowledge preferred.

Responsibilities

• Develop and maintain risk management strategies and plans.
• Lead DFMEA with project teams to evaluate failure modes and risks.
• Review product complaints and implement risk controls.
• Ensure traceability between risk management and design outputs; support design verification/validation.

Skills

Risk management

Design controls

Regulatory compliance

Team collaboration

Self-starter

Fast learner

Education

Bachelor's degree in engineering

Tools

Minitab

Job description

## Ingénieur Qualité IPostuler: Sur site: North Haven, Connecticut, United States of America: Lafayette, Colorado, United States of America: Boston, Massachusetts, United States of America: Temps plein: Offre publiée aujourd'hui: Date de fin : 22 septembre 2026 (Il reste 6 jour(s) pour postuler): R77439We anticipate the application window for this opening will close on - 22 Sep 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 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.This role is onsite 4 days per week, and can be located in North Haven (CT), Boston (MA), or Lafayette (CO). The ideal candidate will have **a strong interest 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 changes**Other potential responsibilities:*** 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.**Minimum Qualifications:*** Bachelors degree in engineering or a related technical field**Preferred Qualifications:*** Experience in **medical devices**, pharmaceuticals, or combination products* Familiarity with **medical device risk management standards** (e.g., ISO 14971 concepts)* Prior involvement in **New Product Development (NPD)** environments* Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles* Clinical knowledge or experience supporting clinical risk assessment* Experience using **Minitab** or other statistical analysis software* Certification or experience with **Design for Six Sigma / Design for Reliability** methodologies* Strong written, verbal, and digital communication skills* Proficiency with **Microsoft Office tools** (Excel, Word, PowerPoint)* **Certifications:** Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.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.**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.Salary ranges for U.S (excl. PR) locations (USD):$66,400.00 - $99,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).## ## The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.