Senior Quality Engineer

About Medtronic

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.

Job Summary

A Day in the Life At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do.

In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

Within the Renal Denervation (RDN) Design Assurance (DA) Laboratory at Medtronic’s Mounds View site, we focus on providing Quality support across all aspects of PDP from pre-market to post market product surveillance. We participate in the design process to ensure the performance and safety of the complex electromechanical devices we develop, is assured and maintained throughout the product lifecycle.

This position is a combined role serving as both the equipment Subject Matter Expert (SME) and a lab support engineer, ensuring robust technical oversight and operational support for laboratory activities.

Key Responsibilities

• Serve as the SME for Design Assurance lab, supporting day-to-day lab activities as well as lab equipment activities
• Create and maintain lab operating procedures and work instructions in accordance with the Quality Management System (QMS) requirements
• Implement and configure the Laboratory Information Management Systems (LIMS)
• Procure, install, verify & validate Lab equipment
• Lead and support root cause investigations relating to test failures and any equipment issues
• Complete Equipment/Software development documentation including URS, Risk Assessment, IQ and EDST (OQ) documents, managing associated change order process
• Identify and drive continuous improvement projects within the lab
• Design and Develop tooling and fixturing to support Test Method development
• Collaborate with project teams to plan and schedule activities necessary to meet timelines

Required Knowledge and Experience

• Experience working in the medical device or other regulated industry
• Baccalaureate degree AND minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience

Preferred Knowledge and Experience

• Knowledge of FDA regulations and ISO 17025, as well as working in a regulated environment
• Experience in electrical engineering principles