Principal Quality Engineer - Post Market Vigilance - NV - Irvine, CA.

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

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 :

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.

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
30+ days ago