Senior Quality Engineer

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 develop innovative medical technologies that improve the lives of 72+ million patients each year.

About the role

The Peripheral Vascular Health (PVH) Operating Unit brings together a broad portfolio of peripheral vascular technologies, products, and services to address the needs of clinicians and patients worldwide. This role supports sustaining and project quality engineering initiatives across manufacturing operations at the Plymouth Nathan Lane facility in Plymouth, Minnesota. This is an onsite position with limited travel requirements.

As a Senior Quality Engineer, you will serve as the quality representative for sustaining and strategic manufacturing projects, partnering closely with cross-functional stakeholders to drive process improvements, support manufacturing excellence, ensure compliance, and provide technical leadership for quality-related project activities.

Responsibilities

• Represent Quality Engineering on manufacturing and operational improvement projects, ensuring quality requirements are integrated into project planning and execution.
• Partner with cross-functional teams to support capacity expansion, equipment replacement, technology implementation, yield improvement, and lean transformation initiatives.
• Analyze manufacturing and quality data using statistical and problem-solving methodologies to identify root causes and implement corrective actions.
• Develop and execute quality engineering deliverables, including risk assessments, qualifications, validations, and technical documentation.
• Review and approve process changes, product dispositions, corrective and preventive actions (CAPA), and other quality system documentation.
• Ensure manufacturing processes and quality activities comply with applicable regulatory, quality system, and internal requirements.
• Generate and implement solutions that improve product quality, process performance, safety, yield, cost, and cycle time.
• Provide technical guidance and mentorship to engineering and operations partners on quality engineering principles and applications.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline and a minimum of 4 years of relevant experience; or an advanced degree and a minimum of 2 years of relevant experience.
• Experience supporting quality engineering activities within a regulated manufacturing environment.
• Experience analyzing technical or process data to drive investigations, root cause analysis, and corrective actions.
• Experience creating, reviewing, or approving technical documentation supporting manufacturing or quality system activities.
• 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.

Preferred Qualifications

• Experience reviewing and approving engineering, validation, or quality documentation.
• Experience with process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience developing, executing, and analyzing Test Method Validations.
• Experience with risk management and validation documentation, including Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Master Validation Records.
• Knowledge of statistical and quality engineering tools such as Design of Experiments (DOE), Statistical Process Control (SPC), capability studies, and hypothesis testing.

Physical Job Requirements

The physical demands described 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: The employee is regularly required to be independently mobile and interact with a computer, as well as communicate with peers and co-workers.

U.S. Work Authorization & Sponsorship

U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above. 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.

Pay

Salary ranges for U.S. locations (excluding Puerto Rico) are $98,400.00 - $147,600.00 USD. 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.

Benefits

The following benefits and additional compensation are available to 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
• 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)
• 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. Some benefits may not apply to workers in Puerto Rico.