Principal Quality Engineer - Neurovascular - Irvine, CA or Mounds View, MN (Finance)

We anticipate the application window for this opening will close on - 9 May 2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development-we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day.

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Learn more about Neuro Vascular OU here .

#Neuroscience

Careers That Change Lives

In this dynamic position as Principal Quality Engineer, you will play a key role in enhancing patient outcomes by driving the timely resolution of post-market quality and product safety concerns. You will lead engineering evaluations of field-reported complaints, analyzing trends related to patient impact, device performance issues, root cause investigations, and ongoing risk assessments through the use of data analytics and signal detection. Supporting the entire Neurovascular product portfolio, you will leverage your expertise in Design Control, Risk Management, quality engineering methodologies, statistics, and data analysis to ensure product safety and regulatory compliance. This role also involves close collaboration with cross-functional Neurovascular teams to implement appropriate product controls based on risk assessments.

Responsibilities may include the following and other duties may be assigned.

Issue Escalation and Evaluation:

• Drive the timely evaluation and resolution of post-market product quality and safety issues to ensure patient safety and optimal care.
• Lead or facilitate investigations into complex technical problems, collaborating closely with cross-functional teams including Manufacturing, Regulatory Affairs, R&D, and Supplier Quality to determine and implement appropriate actions.
• Assess the impact of identified issues through in-depth complaint investigations, health hazard analyses, product holds, and field corrective actions.

Risk Management:

• Apply risk management tools to identify, assess, and mitigate risks throughout the entire product lifecycle.
• Review and evaluate testing protocols and reports to ensure compliance with regulatory requirements and alignment with quality goals.
• Stay up to date on current regulatory standards and requirements relevant to medical device development and commercialization.
• Ensure adherence to FDA regulations, international standards, and Medtronic Neurovascular quality procedures.
• Utilize large datasets effectively through data mining and analysis techniques to support robust risk assessments.
• Maintain deep knowledge of all Neurovascular products and their clinical applications.

Location : Irvine, CA or Mounds View, MN (Onsite)

Ability to travel up to : 25%

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor's degree required with a minimum of 7 years of relevant experience
• OR advance degree with a minimum of 5 years of relevant experience

Nice to Have ( Preferred Qualifications )

• Degree in Engineering, Science or Technical discipline is preferred
• Proven ability to make sound decisions across diverse Quality Engineering functions
• Proficient in project management principles and tools (e.g., Microsoft Project)
• Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• ASQ certification is highly preferred
• Strong foundation in general statistics and data interpretation
• Skilled in risk assessment and mitigation strategies
• Experienced in root cause analysis techniques such as Fishbone Diagrams and 5 Whys
• Familiar with process improvement methodologies including Six Sigma, Design of Experiments (DOE), and LEAN principles
• Standard responsibilities associated with the job code (refer to job description in WD)

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.

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):$116,000.00 - $174,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here .

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.