Sr Quality Engineer, Post Market Risk Management

Careers That Change Lives

In this exciting role as a Senior Post-Market Quality Engineer - Risk Management you will have responsibility for developing and implementing best practices in risk management and for providing Risk Management expertise throughout the product life cycle including development, market release, and post-market activities within the Diabetes Quality organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, performing Corrections & Removals assessments, authoring health hazard evaluations, and assisting in Field Actions.

Diabetes impacts over 500 million people around the world - that's roughly one in 10 adults. That means you probably know someone affected by this disease. At Medtronic, our Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

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

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

• Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase.

• Conduct health hazard assessments or IIAs for fielded products.

• Conduct Corrections & Removals assessments.

• Collaborate cross functionally to perform bounding/scoping for field actions and assist in field action related regulatory inquiries.

• Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes,

• Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discuss the harm severity sources and estimate the probability or harm occurrence.

• Support Complaint trending and Severity trending signal dispositions.

• Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation.

• Actively communicate findings to Quality, Development, and Operations teams and escalates when the risk profile of a medical device adversely changes.

• Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings.

• Develops, modifies, applies and maintains quality standards and protocol for risk management.

• Perform any additional tasks assigned by the management.

Must Have: Minimum Requirements

To be considered for this role, the minimum requirements listed below must be evident on your resume.

Bachelor's degree in Engineering, Science or technical field with 4+ years of experience in quality and/or engineering

OR

Advanced degree in Engineering, Science or technical field with 2+ years of experience in quality and/or engineering

Nice to Have

• 5+ year risk assessment experience

• Experience with EN ISO 14971:2019 and ISO TR 24971:2020

• Excellent communication and technical writing skills

• Experience in Medical Devices

• Experience in Manufacturing and/or software development risk assessments

• Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, analysis tools and methodologies to understand and quantify residual risks.

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)

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. Learn more about our benefits here (~~~) .

This position is eligible for a short-term incentive plan.? Learn more about Medtronic Incentive Plan (MIP) on page 6 here .

The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc. ?

Min Salary

90000

Max Salary

135000

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.