Senior Quality Engineer

Senior Quality Engineer

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

As a Senior Quality Engineer, responsible for preparing and compiling post-market product data and supporting risk management activities for medical devices. Also serves as a mentor to junior engineers by providing guidance, technical support, and best practices in quality engineering within the medical device industry.

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

• Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
• Develop templates and training based on the quality system regulations, applicable standards and guidance.
• Independently review all deliverables to ensure compliance with development process and the standard.
• Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports.
• Deliver presentations and training to the QA organization on status and issues of assigned projects.
• Participate when appropriate in audits.

Required Knowledge and Experience:

• BE/BTech with 8 to 12 years of experience in Risk Management experience
• Experience on PFMEA, DFEMEA and UFMEA or some in Post market quality experience.
• Clinical medical writers.
• Signal Evaluations.
• Hands on experience on EU MDR
• Strong communication.

Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.