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Senior Quality Engineer

$98.4k - $147.6k

Medtronic plc

  • # Senior Quality EngineerPostuler: Sur site: Santa Ana, California, United States of America: Temps plein: Offre publiée hier: Date de fin : 9 octobre 2026 (Il reste 6 jour(s) pour postuler): R73658We anticipate the application window for this opening will close on - 9 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's Interventional Cardiology Therapies (ICT) operating unit is seeking a Senior Quality Engineer to lead and execute post market surveillance activities while serving as a key technical leader within Post Market Quality. This role provides strategic oversight of complaint investigations, complaint trending, risk assessments, regulatory support activities, and quality system improvements across the ICT operating unit. The Senior Quality Engineer will serve as a subject matter expert for post-market quality processes and partner closely with Regulatory Affairs, Clinical Affairs, Medical Safety, R&D, Manufacturing, and Global Quality to evaluate product performance, identify emerging risks, and drive continuous improvement initiatives. The role will also provide mentorship to junior engineers and influence quality strategy for new and released products. This position is in Santa Ana, CA and requires on-site presence for 4 days a week. This position is not open to remote candidates or sponsorship. **Responsibilities may include the following and other duties may be assigned:*** Lead complex complaint investigations, product performance assessments, and root cause analyses for commercially released products* Drive periodic complaint trending activities, identify and evaluate emerging quality signals, assess patient and business risk, and recommend appropriate actions* Provide technical leadership in evaluating complaint data, post-market surveillance information, and field performance trends to support risk management activities* Collaborate with cross-functional teams including Customer Quality Experience Management, Clinical Affairs, Medical Safety, Regulatory Affairs, R&D, Manufacturing, and Reliability Engineering to resolve complex quality issues* Lead quality assessments supporting regulatory submissions, product registrations, regulatory inquiries, and responses to health authority requests* Serve as a subject matter expert for post-market surveillance and complaint handling processes during internal and external audits* Partner with Design Assurance and Risk Management teams to review and evaluate risk files, hazard analyses, FMEAs, benefit-risk assessments, and post-market surveillance strategies* Lead development, maintenance, and continuous improvement of Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-up activities, and other post-market regulatory deliverables* Identify opportunities for process improvement and lead initiatives that enhance quality system effectiveness, operational efficiency, and product quality* Provide technical guidance and mentoring to engineers and investigators while promoting best practices in problem solving and risk-based decision making* Influence quality decisions through sound engineering judgment, data analysis, and effective communication with leadership and cross-functional stakeholders* Prioritize and communicate significant quality concerns, emerging risks, and compliance issues to management and executive leadership as appropriate* Participate in CAPA, nonconformance, and risk evaluation activities, ensuring robust investigation, containment, and corrective actions **Preferred Qualifications*** Advanced degree in engineering, science, or equivalent technical discipline* Knowledge of cardiovascular/implant procedures* Experience with post-market surveillance requirements, complaint handling, risk management, and product performance monitoring* Experience with statistical analysis, data trending, and signal detection methodologies* Experience in a highly regulated industry, preferably implantable medical devices* Knowledge of product development cycles including clinical and regulatory requirements* Demonstrated leadership of cross-functional projects and process improvement initiatives **Required Qualifications*** Bachelor’s degree in engineering, health science, or a technical discipline* Minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience 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 View email address on click.appcast.io.**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):$98,400.00 - $147,600.00This 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).
  • J-18808-Ljbffr Medtronic plc

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