Job Information
Medtronic Principal Quality Engineer - Post Market Vigilance - NV - Irvine, CA in Irvine, California
Careers That Change Lives
In this exciting role as the Principal Quality Engineer, you will be responsible for optimizing patient care by timely resolutions of post-market quality and product safety issues. The position ensures adequate engineering evaluation of field reported complaints including trends in patient impact, device failures, root cause investigation, and on-going risk assessment driven by data analytics and signal detection for neurovascular product sustenance and improvements. This individual will support all Neurovascular products and expected to apply his/her knowledge of Design Control, Risk Management principles and quality engineering techniques, statistics, and data analytics to monitor post market product safety and ensure conformance to all applicable regulatory requirements. Collaborate with Neurovascular cross-functional teams to drive appropriate product control based on risk evaluation.
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.
To learn more about Inclusion & Diversity at Medtronic Click Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)
Neurovascular Operating Unit
The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care.
Location : Irvine, CA
Ability to travel up to : <10%
A Day in the Life
Responsibilities may include the following and other duties may be assigned:
Issue Escalation and Evaluation:
Ensuring product safety and optimizing patient care with timely resolutions of post-market quality and safety issues through issue evaluation and risk assessments.
Lead/facilitate the investigation of complex technical issues and collaborate with the cross-functional partners (Mfg Operations, Regulatory, R&D, Supplier Quality, etc) on appropriate actions.
Evaluate the impact of issues on product including advanced complaint root cause investigation, health hazard analysis, product hold orders, and field corrective action.
Risk Management:
Identifies and manages risk throughout the product lifecycle with the application of risk management tools.
Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
Maintains knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
Comply with applicable FDA and international regulatory laws/standards and Medtronic Neurovascular QA procedures.
Adept at using large data sets using a variety of data mining/data analysis methods and understanding of fundamental Risk Management application.
Comprehensive understanding of all Neurovascular products and clinical uses.
Must Have (Minimum Requirements)
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors degree in Engineering, Science, or Technical Discipline required
Minimum of 7 years of experience, or advanced degree with a minimum of 5 years experience
Nice to Have (Preferred Qualifications)
Demonstrated proficiency in decision making – preferably across a broad spectrum of Quality Engineering responsibilities.
Project management methods and tools (Microsoft Project, etc.)
Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
ASQ Certification
General Statistics Proficiency
Risk Management and Analysis
Root Cause Analysis Techniques (Fishbone, 5 Whys, etc.)
Process Improvement Methodologies, such as Six sigma, DOE, LEAN
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).
Min Salary
116000
Max Salary
174000
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.