Principal Quality Engineer at Medtronic in Northridge, California

Job Description:

Careers That Change Lives

This position will support the Medtronic mission for unsurpassed quality and reliability in our medical devices by providing technical and quality systems expertise within the Post-Market Quality organization. You will serve as a subject matter expert for post-market quality deliverables for new product development programs including planning, developing, and implementing post-market surveillance, trending, complaint investigation and returned product analysis processes.

You will interface with various cross functional teams and represent "Voice of Post-Market Quality" to ensure the entire product life cycle is accounted for in new product development. The ideal candidate will have experience with new product introduction and implementation of pre-market to post-market for medical devices. In this role, you will be responsible for New Product Evaluation activities for the quality organization.

DIABETES OPERATING UNIT :

The Diabetes Operating Unitfocuses 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 theirlives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.

A Day in the Life

This role will be part of Diabetes Post-Market Quality Organization. Individuals in this role will provide technical and quality system expertise on post market quality activities for new product development projects. The ideal candidate for this position has a strong technical background and experience in medical device post market quality requirements, processes, planning and reporting.

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

• Collaborates with engineering, risk management, operations, clinical, medical safety, complaint handling, data analytics and regulatory functions on post market quality deliverables and processes
• Supports new product introduction activities with development of post market quality implementation activities
• Serves as "Voice of Post-Market Quality" for new product development and through the product release process
• Works collaboratively to ensure needs for compliance are considered in all areas of Post-Market monitoring including trending, complaints, failure analysis and post-market surveillance.
• Leads new product evaluation activities for new product development programs for post launch monitoring/escalation
• Develops, modifies and maintains quality system procedures/documentation in area of responsibility
• Performs other related duties as assigned
• Understand complex issues and consult with various functions to conduct meaningful analyses.
• Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations
• Driving clarity and consistency in documentation.
• Work directly with Enterprise/operating entities to ensure compliance to procedures, requirements and meet regulations.

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality

OR

Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.

Nice to Have

• Previous Quality experience working in medical device or related industry with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, M DR, ISO 13485 and/or other relevant international standards. Experience with post market quality processes (complaint handling, failure analysis, risk management and post market surveillance) preferred.
• Strong oral communication, presentation, and technical writing skills
• Strong problem solving and analytical skills. Ability to review/analyze data/trending
• Ability to work effectively within team and across functions
• Must be able to handle multiple tasks/projects and manage priorities accordingly to meet deadlines.
• Knowledge of medical devices, specifically Medtronic Diabetes medical devices a plus, to understand and assess risks/benefits
• Self-Starter with a sharp focus on quality and customer experience.

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 in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.