Senior Principal Quality Engineer - Minneapolis

Medtronic•Minneapolis, MN

1d•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 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’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned.

Requirements

Baccalaureate degree Minimum of 10 years of relevant experience OR Master's degree with a minimum of 8 years relevant experience OR PhD with 6 years relevant experience.

Nice To Haves

Experience leading post-market surveillance programs in the medical device industry
Proven ability to drive process improvements and in developing and implementing systems for trending, analyzing, and reporting product quality data
Knowledge of risk management processes including FMEA and Hazard Analysis
Strong understanding of global regulatory requirements (FDA 21 CFR 820, ISO 13485, EU MDR)
Strong analytical skills with the ability to interpret complex data and identify trends
Effective communicator

Responsibilities

Lead the development and implementation of a comprehensive post-market surveillance trending program to proactively identify and address product quality and safety issues.
Design and optimize processes for collecting, analyzing, and reporting post-market data, including complaints, adverse events, and product returns.
Collaborate with cross-functional teams (Regulatory, R&D, Clinical, etc.) to ensure integration of post-market data into product risk management and continuous improvement initiatives.
Develop and maintain procedures for tagging complaint codes to Hazard Analysis line items, ensuring accurate linkage between real-world events and risk assessments.
Oversee updates to risk management files, including Failure Mode and Effects Analysis (FMEA) and Hazard Analysis, based on trending data and complaint code mapping.
Provide training and guidance to quality and engineering teams on post-market surveillance best practices and complaint code mapping methodologies.
Prepare and present trending analyses, risk updates, and regulatory reports to internal and external stakeholders.
Ensure compliance with global regulations and standards (e.g., FDA 21 CFR 820, ISO 13485, EU MDR) related to post-market surveillance and risk management.
Drive continuous improvement of post-market surveillance processes and tools to enhance product safety and patient outcomes.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. 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)