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 entire 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.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• CAPA (Corrective and Preventive Action): Proficiency in leading lower risk CAPA processes to identify, investigate, and resolve quality issues; Show proficiency with the use of at least 2 Root Cause Analysis tools: fishbone, 5 whys; Being able to explain the differences between containment, correction, corrective action and preventive action;
• Project Management: Being able to lead projects and establish project plans
• Internal and External Auditing: Skills in participating in the backroom during and/or leading internal audits and managing external audits by regulatory bodies and notified bodies;
• Risk Management: Knowledge and application of risk management processes and standards independently such as ISO 14971 for identifying and mitigating risks associated with medical devices. Being able to explain the risk management structure of a product. Be able to establish and make improvements to risk management processes based on standards such as ISO 14971 and industry practices for identifying and mitigating risks associated with medical devices.; being able to train others in the risk management process and applicable standards; being able to establish the risk management structure for a product; Being able to execute Health Risk Assessments (HRA) and explain the difference between P1, P2, severity, sequence to events – coach others through the process; being able to provide guidance on statistically relevant approaches to perform the HRA; being able to establish P1, P2, severity, sequence of events for a novice product (new to the market); being able to establish, execute and communicate a remediation plan
• Internal Supplier Quality Management: Evaluating and establish criteria for internal supplier quality to ensure that materials and components meet regulatory and quality standards.
• Test Method Validation – Lead the planning and execution of test method validations following established procedures. Being able to differentiate between continuous and attribute data to determine the relevant sample size. Being able to identify approaches to optimize the sample size. Being able to coach team members on the identification of challenge samples. Being able to provide a rationale and a plan for the TMV remediation, as needed.
• Equipment Qualification – Lead the planning and execution o