Senior Quality Engineer

Medtronic•Mounds View, MN

2d•Onsite

About The Position

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 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.

Requirements

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

Nice To Haves

Knowledge of FDA regulations and ISO 17025, as well as working in a regulated environment
Experience in electrical engineering principles
Experience of validating or developing Test Methods

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

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)