Senior Quality Engineer - 2nd shift

Medtronic plc; West Valley City (UT); In loco; USD 98.000 - 148.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health, Dental and vision insurance

401(k) plan with employer match

Tuition assistance/reimbursement

Life insurance

Disability leave

Employee Stock Purchase Plan

Descrizione del lavoro

Medtronic plc in the United States seeks a Senior Quality Engineer to lead process validation, CAPA and NCMR activities within a regulated medical device environment. This onsite role partners with manufacturing and engineering to ensure compliant, high-quality processes and products.

Based at the West Valley City, Utah facility, the position emphasizes data-driven decision making, mentoring colleagues, and adherence to quality systems and CFR requirements.

Competenze

• Experience in regulated manufacturing environments, with emphasis on quality engineering and validation processes.
• Familiarity with CFR requirements and quality systems in medical device or pharmaceutical settings.
• ASQ CQE, Lean Six Sigma or similar certification is preferred.

Mansioni

• Lead process validation activities across the full lifecycle from planning to monitoring.
• Collaborate with manufacturing and engineering to enforce quality standards and process controls.
• Drive CAPA and NCMR investigations to prevent recurrence and improve quality.

Conoscenze

Process validation

CAPA

NCMR

Statistical analysis (Minitab)

CFR knowledge

CQE/Lean Six Sigma

Formazione

Bachelor's degree in Engineering, Science, or technical field

Master's degree in Engineering, Science, or technical field

PhD

Strumenti

Minitab

Descrizione del lavoro

We anticipate the application window for this opening will close on - 2 Nov 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

The Operations Quality team partners with manufacturing, engineering, and technical functions to ensure compliance, process capability, product quality, and continuous improvement across manufacturing operations. As a Senior Quality Engineer, you will provide quality engineering support for manufacturing operations with a primary focus on process validation and quality system execution. This role partners closely with engineering and manufacturing teams to ensure compliant, effective, and sustainable manufacturing processes while driving product quality, process reliability, and regulatory compliance within a highly regulated medical device environment. This position is based at our manufacturing facility in West Valley City, Utah, and requires an onsite work schedule of Monday through Thursday, 3:30 p.m. to 2:00 a.m. (second shift).

Primary Responsibilities

• Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.
• Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.
• Drive root cause investigations, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.
• Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.
• Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.
• Support qualification and validation of manufacturing equipment, processes, and test methods.
• Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.
• Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects.

Required Qualifications

• Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience OR Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience OR PhD.
• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related engineering discipline; advanced degree preferred.
• Experience leading process validation activities for complex manufacturing processes in regulated environments.
• Experience with FDA-regulated medical device or pharmaceutical manufacturing.
• Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.
• Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
• ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification.
• 2+ years of experience executing process validation activities across the full validation lifecycle.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8C.F.R. §214.2(h)(4)(iii)(A) is required.

Preferred Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related engineering discipline; advanced degree preferred.
• Experience leading process validation activities for complex manufacturing processes in regulated environments.
• Experience with FDA-regulated medical device or pharmaceutical manufacturing.
• Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.
• Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
• ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification.
• 2+ years of experience executing process validation activities across the full validation lifecycle.

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.

Recruitment Fraud Alert

We 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 [e-mail].

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 pertaining 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.

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.

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.

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…

The 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. Better outcomes for our world. Here, it’s about more than the bottom line.

Our Mission to improve human welfare drives us. We advance…

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.

For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail] To request removal of your personal information from our systems please email [e-mail]