We anticipate the application window for this opening will close on - 31 May 2025

 

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 the Senior 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.

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 or Mounds View, MN

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 (Manufacturing 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.

  • Support product evaluation board processes for complaint trending and signal analysis.

• 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.

• Bachelor degree with minimum of 4 years of relevant experience,

• Or advanced degree with a minimum of 2 years relevant experience.

Nice to Have (Preferred Qualifications)

• Degree in Engineering, Science, or Technical Discipline is desired.

• Proven expertise in decision-making across a wide range of Quality Engineering functions

• Proficient in project management methodologies and tools

• In-depth knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)

• ASQ certification (e.g., CQE, CQA) preferred

• Strong foundation in statistical analysis and data interpretation

• Skilled in risk management and risk analysis techniques

• Experienced in process improvement methodologies, including Six Sigma, Design of Experiments (DOE), and Lean principles

• Thorough understanding of ISO standards, particularly