Senior Quality Engineer

Senior Quality EngineerCareers 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.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 Senior Quality Engineer 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 met.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.Works with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations.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 solutionsMay 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 4 years of relevant experience in Engineering and/or Quality OR Master's degree in Engineering, Science or technical field with a minimum of 2 years relevant experience OR PhD in Engineering, Science or technical field with 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).Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.Six Sigma or Lean Sigma belt certificationDRM or DFSS certificationExperience with internal and external audits including FDA, MDSAP and/or TUV.4+ years of engineering experience in a medical device manufacturing environment4+ years of Process Quality or Process Engineering experience.Strong understanding of medical device manufacturing processes and productsExperience with general quality principles, procedures and methodologiesStrong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)Strong statistical analysis techniques & DOE design and executionStrong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applicationsFor 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 & SponsorshipAt 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits Package 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.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, Medtronic Plc