Quality Engineer II

MED Medtronic Inc; Tempe (AZ); On-site; USD 71,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Tuition assistance

Employee Stock Purchase Plan

Job summary

Medtronic Tempe Campus is seeking a Quality Engineer II to oversee quality and compliance for the process development and manufacturing of implantable cardiac and neuromodulation devices.

The role partners with engineering and operations to drive key quality initiatives across Tempe's Wafer & Sensor Operations and Hybrid Manufacturing Operations, with patient safety and regulatory compliance at the forefront.

Qualifications

• Requires a degree in Engineering, Science or technical field with 2+ years of relevant experience OR a Master's degree with 0+ years relevant experience.
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly preferred.
• Six Sigma or Lean Sigma belt certification preferred.
• Experience with supporting internal or external audits including FDA, MDSAP and/or TUV preferred.

Responsibilities

• Develops and maintains quality standards and protocols for materials processing.
• Ensures internal quality processes comply with governing standards.
• Collaborates with engineering and manufacturing to uphold quality standards.
• Implements inspection/testing methods and analyzes product and equipment quality.
• Supports CAPA investigations and improvements and effectiveness verification.
• Leads or supports investigations of non-conforming product and communicates findings.

Skills

Quality engineering

Statistical analysis

DOE

CAPA

Education

Engineering degree

Master's degree

Job description

Career Overview

We anticipate the application window for this opening will close on - 21 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 Quality Engineer II 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 in place.
• 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.
• 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 2 years of relevant experience OR Master's degree in Engineering, Science or technical field with a minimum of 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).
• Solid background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
• Six Sigma or Lean Sigma belt certification
• Experience with supporting internal or external audits including FDA, MDSAP and/or TUV.
• 2+ years of engineering experience in a medical device manufacturing environment
• 2+ years of Process Quality or Process Engineering experience.
• Understanding of medical device manufacturing processes and products
• Experience with general quality principles, procedures and methodologies
• Experience assessing compliance to regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Applied 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

• Salary ranges for U.S (excl. PR) locations (USD):$79,200.00 - $118,800.00
• 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).
• 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).
• 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.

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.

For further information about the E‑Verify program.