Quality Engineer II – Post Market Surveillance

Careers that Change Lives

We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Quality Engineer II ensures product safety and optimizing patient care by timely resolutions of safety and compliance issues. The position performs issue identification and investigation through software/engineering analysis of aggregated complaint trending involving but not limited to patient impact, device failures, root cause investigation, and on-going risk assessment driven by data analytics for Neurovascular product sustenance and improvements. For all Neurovascular products, this individual is expected to apply his/her knowledge of Engineering, Risk Management principles, Statistics, and Data Analytics to ensure product safety and conformance to all applicable regulatory requirements. Evaluation of product safety is heavily based on collaboration with Neurovascular cross-functional teams to drive appropriate product control.

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Put Patients First is a strategic enterprise imperative that reinforces those patients are at the center of all our decisions and actions, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

This position is in Irvine, CA.

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

In general, the following responsibilities apply for the Quality Engineer II. This includes, but is not limited to the following:

• Issue Escalation and Evaluation:
  • Through statistical trending techniques, identify safety signals for issue escalation and evaluation.
  • Lead/Facilitate the investigation of complex technical issues and collaborate with cross-functional Engineering groups on appropriate actions.
  • Analysis of the impact and actions of issues on product, including risk assessments, advanced complaint root cause investigation, product hold orders, and field corrective action.
• Risk Management:
  • Identifies and manages risk throughout the product lifecycle with the application of risk management tools. 
  • Comply with applicable FDA and international regulatory laws/standards and Medtronic Neurovascular 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.
• General:
  • Evaluate and develop new software tools in order to better detect signals and perform risk assessments.

• • Promotes a continuous improvement culture and proactive utilization of quality tools.
  • Represent Medtronic Neurovascular as appropriate in FDA, notified body, internal, and external audits.

The successful candidate will have

• Inquisitive and critical thinking mindset
• Demonstrated oral, presentation and technical writing skills
• Proven proficiency with PowerBI, PowerQuery, Minitab/JMP, Excel Macros or similar software and programming tools
• Understanding of Software Development and Validation processes
• Experience with Risk Analysis and Assessment (in accordance with ISO 14971, EU MDR, MDSAP)
• Knowledge of ISO and regulatory standards; such as 13485 and 14971, EU MDR, FDA QSR, MDSAP

Qualifications -

MUST HAVE - MINIMUM REQUIREMENTS:

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelor’s degree required in Engineering, Science or technical discipline

• Minimum of 2 years relevant work experience in Engineering and/ or Quality or advanced degree with a minimum of 0 years of relevant experience in a regulated environment

Nice to Have

• Process Improvement Methodologies, such as Six sigma, DOE, LEAN
• Familiarity with Project management methods and tools
• Sound Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• ASQ Certification

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)