Sr. Pre-Market Supplier Quality Engineer (CV CRHF)

Medtronic plc; Mounds View (MN); On-site; USD 99,000 - 149,000; Full time

Benefits offered by this job

Health insurance

Dental and vision insurance

401(k) plan plus employer contribution

Paid time off

Job summary

Medtronic plc is seeking a Pre-Market Supplier Quality Engineer to partner with Design, Reliability and Technical Sourcing to develop and release cost-effective components and materials for medical devices. You will drive qualification and validation, lead supplier audits and ensure GMP/ISO compliance across the NPD lifecycle.

Responsibilities include problem solving using DMAIC/DOE, analyzing data with Minitab and MS Excel, and maintaining robust supplier quality processes to prevent defects

Qualifications

• Bachelor's degree in engineering, science or technical field with 4+ years of work experience in Engineering and/or Quality.
• Advanced degree with 2+ years of experience in Engineering and/or Quality.
• 2+ years supplier quality engineering in medical device or related field preferred.
• ASQ CQE or Lead auditor certifications are desirable.
• Knowledge of PPAP, GMP/ISO requirements and supplier controls.

Responsibilities

• Partner with Design, Reliability and Sourcing to identify and develop cost-effective components and materials.
• Drive qualification, validation and release activities for new and existing components.
• Lead supplier audits and implement corrective and preventive actions.
• Ensure GMP/ISO compliance and maintain quality documentation.

Skills

Supplier Quality Engineering

PPAP

ASQ CQE

DMAIC

DOE

Gage R&R

Statistical Quality Control

MS Excel

Minitab

Education

Bachelor's Degree in Engineering, Science or technical field

Advanced degree

Tools

Minitab

MS Excel

Job description

We anticipate the application window for this opening will close on - 11 Sep 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 Careers That Change Lives As a Pre-Market Supplier Quality Engineer, you will be responsible for partnering with Design, Reliability and Technical Sourcing to identify to develop, qualify and commercially release cost effective components and materials for use in the OUs products. In this area of new product development, the Supplier Quality Engineer will be required to drive multiple aspects of component and material development, qualification and validations with suppliers as a member of a cross-functional team. Cardiac Ablation Solutions CAS provides a broad suite of electrophysiology solutions intended to disrupt and lead the market in cardiac mapping and ablation technologies for arrhythmia management. These clinical and economical solutions will enable clinicians to treat patients with safer, faster and easier, and with more predictable procedure times and outcomes. Ensures that suppliers deliver quality parts, materials, and services Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness Partner with Technical Sourcing to locate, evaluate, and approve new potential component/material suppliers that balance business, quality, and technical requirements. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Lead issue resolution of complex problems as they relate to supplied components and materials. Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products. Perform process and component/material development work with suppliers to deliver highly capable components/materials. Applies principles of chemistry, physics and material behaviors in the development of supplier processes. Define component qualification strategy, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Support project deliverables, supply risk reduction, yield improvement and cost reduction activities during development. Perform detailed analysis of component and material qualification data using Minitab and MS EXCEL software to ensure specification and capability requirements are met. Author component and material characterization, qualification and product acceptance documentation supporting supplier qualification activities. Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements. Drive supplier requirements by collaborating with Development Engineering and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk. Partner with suppliers to ensure components are designed for reliability, manufacturability, and cost. This role will develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products. Work to develop proper inspection tooling and test methods for new components to ensure supplier parts meet specification requirements. Perform statistical data analysis to determine tool and part/process performance. Evaluate Supplier capabilities for mechanical measurement via Gage R&R studies. Ensure appropriate acceptance activities are in place prior to commercialization. Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods. Prepare and negotiate Quality Agreements with suppliers Develop technical solutions to complex problems using the corrective/preventative action process Lead or participate in supplier audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements Must Have: Minimum Requirements (To be considered for this role, please ensure the minimum requirements are evident on your resume): Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality Nice to Have 2+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise. Working knowledge of PPAP process ASQ CQE certification ASQ Lead auditor certification Manufacturing processes or R&D experience Firm understanding of inspection and manufacturing processes (laser micrometers, optical measurement systems, tool scopes, injection molding, thermoforming, metal forming/machining, etc.) Some level of Experience with qualifying with Contract Manufacturing. Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls PC skills, MS Office (Minitab, Word, Excel, PowerPoint and Project) Working advanced knowledge level of statistics and DOE execution Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485 Strong communication skills; both written and oral to internal and external customers including strong interpersonal skills to enable working across multiple functions such as Design Engineering, Sourcing, Commodity Management and Quality to resolve issues Strong problem-solving skills (DMAIC, Kepner Trego, Fishbone, etc.) – Green Belt DRM or 6S

About Medtronic

About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America). A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here. The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and 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.

Salary and Compensation

Salary ranges for U.S (excl. PR) locations (USD):$99,200.00 - $148,800.00 Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 64,640.00 EUR - 96,960.00 EUR | This 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).

Benefits

• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

EEO Statement

La politique de Medtronic consiste à assurer l'équité en matière d’emploi (EEO) à toutes les personnes, indépendamment de l'âge, de la couleur de peau, de la nationalité, du statut de citoyenneté, d'un handicap physique ou mental, de la race, de la religion, des croyances, du genre, du sexe, de l'orientation sexuelle, de l'identité et/ou expression de genre, des informations génétiques, de l'état matrimonial, du statut au regard de l'assistance publique, du statut d'ancien combattant ou de toute autre caractéristique protégée par la loi nationale, fédérale ou locale. En outre, Medtronic proposera des aménagements raisonnables aux personnes qualifiées ayant un handicap. Chez Medtronic, la plupart des postes sont publiés sur notre site dédié aux offres d’emploi pendant 3 à 7 jours. Nous sommes à la pointe de la technologie mondiale en matière de soins de santé et nous nous attaquons avec audace aux problèmes de santé les plus difficiles auxquels l’humanité est confrontée en recherchant et en trouvant des solutions. Notre mission (soulager la douleur, restaurer la santé et prolonger la vie) rassemble une équipe mondiale de plus de 95 000 personnes passionnées. Nous sommes des ingénieurs dans l'âme et nous mettons en œuvre des idées ambitieuses pour trouver de véritables solutions pour des personnes bien réelles. Du laboratoire de R&D à l’usine, à la salle de conférence, tous nos collaborateurs expérimentent, créent, construisent, améliorent et cherchent des solutions. Nous disposons des talents, des perspectives les plus diverses et du courage nécessaires pour réaliser des projets extraordinaires.

La politique de Medtronic consiste à assurer l'équité en matière d’emploi (EEO) à toutes les personnes, indépendamment de l'âge, de la couleur de peau, de la nationalité, du statut de citoyenneté, d'un handicap physique ou mental, de la race, de la religion, des croyances, du genre, du sexe, de l'orientation sexuelle, de l'identité et/ou expression de genre, des informations génétiques, de l'état matrimonial, du statut au regard de l'assistance publique, du statut d'ancien combattant ou de toute autre caractéristique protégée par la loi nationale, fédérale ou locale. En outre, Medtronic proposera des aménagements raisonnables aux personnes qualifiées ayant un handicap.

Pour les commerciaux et autres employés de terrain en contact direct avec les patients, se rendre dans un établissement de soins est considéré comme une fonction essentielle du travail et nous attendons de nos employés qu’ils se conforment à toutes les exigences d’accréditation dans les hôpitaux ou cliniques qu’ils soutiennent. Cet employeur participe au programme fédéral « E-Verify » pour confirmer l’identité et l’autorisation d’emploi de tous les employés récemment embauchés. Pour plus d’informations sur le programme « E-Verify », veuillez cliquer ici(https://www.e-verify.gov/employees). Pour obtenir des mises à jour sur les offres d’emploi, veuillez vous rendre sur la page de connexion des candidats et vous connecter pour vérifier l’état de votre candidature. Si vous avez besoin d’aide pour remplir votre candidature, veuillez envoyer un e-mail à [e-mail] Pour demander la suppression de vos informations personnelles de nos systèmes, veuillez envoyer un e-mail à [e-mail]