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

We anticipate the application window for this opening will close on - 11 Sep 2026Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.A Day in the LifeCareers That Change LivesAs 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 SolutionsCAS 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 servicesQualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectivenessPartner 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 suppliersDevelop technical solutions to complex problems using the corrective/preventative action processLead or participate in supplier audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirementsMust 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 QualityNice to Have2+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.Working knowledge of PPAP processASQ CQE certificationASQ Lead auditor certificationManufacturing processes or R&D experienceFirm 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 controlsPC skills, MS Office (Minitab, Word, Excel, PowerPoint and Project)Working advanced knowledge level of statistics and DOE executionWorking 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 13485Strong 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 issuesStrong problem-solving skills (DMAIC, Kepner Trego, Fishbone, etc.) – Green Belt DRM or 6SAbout MedtronicTogether, 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 RequirementsThe 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.For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe 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 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.U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io. ‌Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.Salary ranges for U.S (excl. PR) locations (USD):$99,200.00 - $148,800.00Pay 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).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.Further details are available at the link below:Medtronic benefits and compensation plansIt 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.If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.SummaryLocation: Mounds View, Minnesota, United States of America; Newton, Massachusetts, United States of America; Galway, County Galway, IrelandType: Full time