We anticipate the application window for this opening will close on - 19 Sep 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

Careers that Change Lives 

Our space, the medical device and healthcare industry, is rapidly changing.  It always has been that way.  Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more.  Experience what it’s like to work at a company with an exciting product pipeline of patented inventions driving innovation in the healthcare space. 

The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that will enhance lives as we embody a culture of accountability and trust. 

Over the past 20 years, we have become the global market leader in three key segments – image-guided surgery, intraoperative nerve monitoring, and powered surgical instruments. We continue to launch valuable ENT solutions in tissue health and balloon sinus dilation. 

Responsibilities may include the following and other duties may be assigned: 

• Support the development of investigation guidance and technical analysis of product complaints, ensuring timely resolution and consistency in supporting documentation and reportability decisions. 

• Investigate and bound product quality issues for containment and corrective action. 

• Support the development and maintenance of risk management/ complaint analysis procedures to support business efficiency in alignment with applicable regulations.  

• Lead or support updates to product risk management files based on post-market data in alignment with ISO 14971:2019 and applicable regulations. 

• Perform advanced analysis of quality data (including complaints, CAPA, and post-market surveillance) using tools such as Microsoft Excel, Power BI, VBA, and statistical methods to identify trends, drive root cause investigations, and support data-driven decision making. 

• Support and organize responses to regulatory inquiries about post-market quality data. 

• Prepare and participate in internal and external audits in the areas of risk management and post-market regulatory compliance. 

• Support activities from CAPAs, audits, quality plans, or other regulatory commitments. 

Must Have: Minimum Requirements 

• Bachelor’s degree required in Mechanical Engineering, Electrical Engineering, Computer Engineering, or a technical field. 

• Minimum of 4 years of Quality Engineering experience or advanced degree with a minimum of 2 years relevant experience. 

To Be Successful in this role: 

• Experience in the medical device, in-vitro diagnostics or pharma industries 

• Strong knowledge of ISO 13485/FDA 21 CFR Parts 803, 806, 820 and ISO 14971 

• Experience in analyzing quality data and driving root cause determination 

• Experience with statistics and statistical techniques as it applies to sample size determination, trends, risk management related calculation such as P1 and P2, etc. 

• Experience with project/program management 

Nice to Have