Quality Engineer -Post-Market at Medtronic in Los Angeles, California

Job Description:

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
In this exciting role as a 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.

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

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 .

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.