Ingénieur Qualité II

Medtronic plc; Tempe (AZ); Hybrid; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with company match

Paid time off and holidays

Job summary

Medtronic plc is seeking a Quality Engineer II on site in Tempe, AZ, to oversee quality and compliance for implantable cardiac and neuromodulation devices. You will partner with engineering and operations to implement robust quality controls, perform statistical analysis, and lead CAPA investigations to ensure patient safety and product reliability.

The role emphasizes experience with process development, IQ/OQPQ, DOE, FMEA and risk assessments, with opportunities to influence across Wafer &

Qualifications

• Requires a bachelor's degree in Engineering, Science or technical field with a minimum of 2 years of relevant experience, or a master's degree with 0 years of relevant experience.
• Experience in medical device manufacturing is preferred and a strong quality mindset is essential.
• Solid knowledge of quality mechanisms, regulatory expectations (ISO, FDA-GMP) and risk assessment methods.

Responsibilities

• Develops, maintains and improves quality standards and protocols for processing materials into finished products.
• Ensures internal quality processes comply with governing standards and requirements.
• Collaborates with engineering and operations to implement quality controls and testing methods.
• Leads investigations on non-conformances, facilitates CAPA and communicates findings to cross-functional teams.

Skills

Electronics manufacturing

Quality systems

Statistical analysis

DOE

Process validation

FMEA

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

## Ingénieur Qualité IIPostuler: Sur site: Tempe, Arizona, United States of America: Temps plein: Offre publiée il y a 2 jours: Date de fin : 21 septembre 2026 (Il reste 7 jour(s) pour postuler): R75580We anticipate the application window for this opening will close on - 21 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**At 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 onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Quality Engineer II you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable Cardiac and Neuromodulation medical device related products at Medtronic’s Tempe Campus. Role includes providing a strong partnership with engineering and operations functions to support key Quality initiatives across campus in Tempe's Wafer & Sensor Operations (WSO) and Hybrid Manufacturing Operations areas. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. Responsibilities may include the following and other duties may be assigned.* Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.* Ensures internal quality processes, procedures and systems are compliant to all governing standards.* Collaborates with engineering and manufacturing functions to ensure quality standards are in place.* Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.* Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.* Supports manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Development (characterization), OQPQ and Test Method Development and Validation.* Uses knowledge of statistics on acceptance criteria, DOE, and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.* Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.* Supports risk assessment processes for manufacturing and development including process FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.* Develops and supports solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.* Supports CAPA investigations, improvements and effectiveness verification testing.* Lead and/or support investigations of non-conforming product, materials or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer. Responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.* Supports and drives proper change control procedures and collaborates with change owners on their implementation strategies and change documentation.* Facilitates group meetings and project leadership that drives comprehensive technical solutions in your quality domain.* Communicates clearly regarding technical issues and solutions* May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.**Required Knowledge and Experience:** Requires a Baccalaureate degree in Engineering, Science or technical field and minimum of 2 years of relevant experience OR Master's degree in Engineering, Science or technical field with a minimum of 0 years relevant experience.**Nice to Have (Preferred Skills)*** Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).* Solid background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.* Six Sigma or Lean Sigma belt certification* Experience with supporting internal or external audits including FDA, MDSAP and/or TUV.* 2+ years of engineering experience in a medical device manufacturing environment* 2+ years of Process Quality or Process Engineering experience.* Understanding of medical device manufacturing processes and products* Experience with general quality principles, procedures and methodologies* Experience assessing compliance to regulatory requirements (i.e.: ISO, FDA-GMP, etc.)* Applied statistical analysis techniques & DOE design and execution* Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applicationsPour 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):$79,200.00 - $118,800.00This 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.