New Product Development Senior Supplier Quality Engineer

Medtronic plc; North Haven (CT); Hybrid; USD 98,000 - 148,000; Full time

Benefits offered by this job

Competitive salary

Flexible benefits

Job summary

Medtronic North Haven, CT is seeking a Senior Quality Engineer to join the New Product Development quality team within the Surgical Operating Unit. The role focuses on manufacturability, inspection and assembly, supplier collaboration, and PPAP qualification to ensure robust processes and uninterrupted supply through design transfer.

You will lead supplier selection, monitor manufacturing cycles, manage NCMRs, support process validation, CAPA, and cross-functional design transfer activities,

Qualifications

• Bachelor’s degree in engineering or related technical field with a minimum of 4 years of relevant experience, or advanced degree with at least 2 years.
• Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product level assembly.
• Regulatory knowledge in a regulated environment (FDA, ISO 13485, ISO 14971).
• Strong analytical and problem-solving skills with the ability to conduct root cause analysis.
• Excellent written and verbal communication skills with cross-functional collaboration abilities.

Responsibilities

• Supplier selection and qualification ensuring delivery of quality parts, materials and services.
• Monitor parts from acquisition through manufacturing cycle and resolve supplier-related issues.
• Evaluate supplier capabilities to meet product, process, quality and business requirements.
• Manage Non-Conformance Material Reports (NCMRs) for material and production issues.
• Manage supplier change requests, reporting and project management.
• Oversee Approved Supplier List including audits and supplier acceptance.
• Qualify materials via PPAP including process validation and technical writing.
• Drive supplier performance improvement and reduce escapes via CAPA and quality reviews.
• Oversee Process validation (IQ/OQ/PQ) and Master Validation Planning.
• Statistical analysis of manufacturing process performance; oversee FMEA and DFx activities.
• Collaborate cross-functionally to capture process controls in design transfer and DFx activities.
• Use project management to ensure supplier processes support engineering builds and design verification.
• Occasional travel to suppliers in the US and internationally.

Job description

## New Product Development Senior Supplier Quality EngineerPostuler: Sur site: North Haven, Connecticut, United States of America: Temps plein: Offre publiée aujourd'hui: Date de fin : 23 octobre 2026 (Il reste 29 jour(s) pour postuler): R78213We anticipate the application window for this opening will close on - 23 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, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Quality Engineer to join our innovative team. This role will be in the Surgical Operating Unit within the new product development quality team to influence design based on manufacturability, inspection and assembly, interact with suppliers (internal and external) to develop robust processes to manufacture the parts and assemblies, qualify the manufacturing processes established to produce sustainable supply and maintain supply and manufacturing continuity until product transfer. The ideal candidate will bring a strong background in manufacturing processes, manufacturing process development, process controls, process validation and supplier management. The role also supports medical device product development, and a solid understanding of design controls and regulatory compliance requirements is preferred. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This role will be pivotal in ensuring the development of medical devices that drive successful design transfer. **Key Responsibilities:*** Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.* Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.* Evaluate supplier technical and manufacturing capabilities to meet product, process, quality, and business requirements as an input to supplier selection.* Manage Non-Conformance Material Reports (NCMRs) for material, components and production related issues, ensuring trends are identified, analyzed, and addressed across incoming, production, and sterilization areas.* Manage suppliers' change requests, including communication, project management, and regular reporting.* Manage the Approved Supplier List, from supplier evaluation, supplier agreement, supplier audits to supplier acceptance.* Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.* Drive supplier performance improvement and reduce escapes to manufacturing through effective issue escalation, Supplier CAPA management, and Quality Performance Reviews.* Oversee Process validation (IQ/OQ/PQ) and Master Validation Planning in new product development.* Perform Statistical analysis of manufacturing process performance outputs* Oversee Process Failure Mode and Effect Analysis (internally and externally)* Collaborate cross functionally to ensure process limitations are captured within the design control, including Design Failure Mode and Effects Analysis and Design for Manufacturability and Assembly activities.* Collaborate cross functionally to ensure essential components, product features and respective process controls are identified.* Ensure Design Transfer effectively translates design specifications into production specifications.* Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.* The job requires occasional travel to visit suppliers within the United States and internationally.**Qualifications:****Minimum Requirements:*** **Education:**Minimum bachelor’s degree in engineering, or a related technical field AND minimum 4 years of relevant experience. OR advanced degree with a minimum of 2 years relevant experience.* **Technical Knowledge:** Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product level assembly. Extensive understanding of GD&T, FMEA, DFX principles.* **Regulatory Knowledge:** Extensive experience in a regulated environment.* **Problem-Solving:**Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.* **Communication:**Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.* **Leadership:**Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.**Preferred Qualifications:*** **Certifications**: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.* **Regulatory Knowledge:** In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.* **Technical Skills:** Proficient in quality management systems, risk management, regulatory compliance, and statistics. Lead auditor experience.* **Other:** Basic knowledge of human anatomy/physiology and surgical procedures* **Tools:** SAP, Trackwise, Windchill, AgileAt 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 a minimum of 4 days a week onsite as part of our commitment to fostering a culture of Professional growth and cross-functional collaboration as we work together to engineer the extraordinary.**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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.The physical demands described within the Day in the Life 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.**EEO**It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees.**How to Apply:**Interested candidates should submit their resume and cover letter through the Medtronic careers portal at [insert application link].Join us in our mission to alleviate pain, restore health, and extend life. Apply today! **TECHNICAL SPECIALIST CAREER STREAM:**An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.**DIFFERENTIATING FACTORS****Autonomy:**Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.**Organizational Impact:**May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.**Innovation and Complexity:**Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.**Communication and Influence:**Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.**Leadership and Talent Management:**May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.**Required Knowledge and Experience:** Requires a Baccalaureate degree and 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 [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):$98,400.00 - $147,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).