Senior Quality Engineer

MED Medtronic Inc; Tempe (AZ); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) with employer match

Tuition assistance

Job summary

Medtronic, a global healthcare technology leader, is hiring a Senior Quality Engineer for the Tempe Campus. The role focuses on quality and compliance of process development and manufacturing of implantable cardiac and neuromodulation devices, collaborating with engineering and operations to enhance product quality.

The position requires a degree in engineering or related field with multiple years of experience in medical device quality, knowledge of ISO/FDA-GMP, and statistics/DOE.

Qualifications

• Requires a degree in engineering, science or technical field with 4+ years of relevant experience, or a master's with 2+ years, or PhD with 0 years.
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly is a plus.
• Strong background in equipment development, IQ, process characterization, OQPQ, and test method development.
• Six Sigma/Lean Sigma DRM or DFSS certification preferred.
• Experience with FDA, MDSAP and/or TUV audits.

Responsibilities

• Develop, apply and maintain quality standards and protocols for processing materials into finished products.
• Ensure internal quality processes are compliant with governing standards.
• Collaborate with engineering and manufacturing to meet quality targets.
• Design and implement inspection and testing methods and statistical analyses.
• Support design outputs and process validations with cross-functional teams.
• Lead or support CAPA investigations and risk assessments.
• Drive change controls and document management in quality systems.
• Provide clear communication on technical issues and solutions.

Skills

Quality Engineering

Statistical Analysis

DOE

Regulatory Knowledge

Education

Engineering degree

Job description

We anticipate the application window for this opening will close on - 9 Sep 2026.

Careers 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 Life

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

• 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 solutions May 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 certification DRM or DFSS certification.
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience.
• Strong understanding of medical device manufacturing processes and products
• Experience with general quality principles, procedures and methodologies
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Strong statistical analysis techniques & DOE design and execution
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• 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 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 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.

Benefits & Compensation

Medtronic 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 - $147,600.00 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 plans

Equal Employment Opportunity

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.

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.

Company Philosophy

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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.

Additional Practical Information

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

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.