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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

Quality Engineer II

Careers that Change Lives

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Quality Engineer II is responsible for the owning and executing post market surveillance activities. Furthermore, this role is responsible for overall operation of Post Market Quality specifically overseeing the execution of Complaint investigations, complaint trending, providing complaint data for regulatory inquiries and submissions, PSURs, etc. within the SHA operating unit (Structural Heart and Aortic). See additional responsibilities section for more details.

The Structural Heart and Aortic integrated operating unit offer minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta.

Key Technologies:

• Evolut TAVR devices

• Harmony TPV

• Confida Guidewire

This position is in Santa Ana, CA within the Structural Heart and Aortic (SHA) operating unit and requires on-site presence three days a week. This position is not open to remote candidates.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Quality Engineer II . This includes, but is not limited to the following:

• Leads complaint investigations, conducts periodic trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required.

• Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D engineering and manufacturing to perform thorough complaint investigation.

• Prepares appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team.

• Partners with design assurance team on risk analysis of new products by reviewing files such as product hazard analysis, DFMECA, post market surveillance plan, risk management report, etc.

• Owns and maintains periodic safety update report (PSUR) by collaborating with several cross-functional teams for applicable devices.

• Develops solutions to unique issues with wide range of difficulty. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation across functions and/or businesses which may cause redirection.

• Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business.

Qualifications

MUST HAVE - MINIMUM REQUIREMENTS:

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelor’s degree in engineering, health science, or a technical discipline

• Minimum of 2 years of work experience in Engineering, Science, OR Advanced degree in Engineering, Science, or technical discipline with 0 years of work experience.

Nice to Have

• Advanced degree in engineering, science, or equivalent technical discipline

• Demonstrated understanding of cardiovascular/implant procedures.

• Experience in a highly regulated industry, preferably implantable medical devices

• Knowledge of product development cycles including clinical and regulatory requirements

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

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):$76,000.00 - $114,000.00

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).

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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 90,000+ 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 (http://www.medtronic.com) .

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.

At Medtronic, most positions are posted on our career site for 3-7 days.

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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 90,000+ 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.

For sales reps and other patient facing field employees, going into a healthcare setting is 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 (https://www.e-verify.gov/employees) .

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