Risk Management Quality Engineer II - New Product Development (Surgical)

About the role

The Role: 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

• Develop and maintain comprehensive strategies for risk management activities, including:
• Collaborating cross-functionally to ensure the utmost product quality for patient safety
• Creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews
• Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures
• Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts
• Analyzing and reviewing product complaints to anticipate and prevent future issues
• Integrating product security measures to protect against potential vulnerabilities into the risk management file
• Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file
• Leading design review and maintaining the risk management file throughout the product lifecycle
• Developing and managing post-market surveillance plans to monitor product performance and safety in the field
• Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch
• Evaluating the safety risk implications of design changes

Requirements

• Bachelor's degree in engineering or a related technical field, plus 2 years related work experience, OR Advanced degree plus 0-2 years related work experience
• Experience in medical devices, pharmaceuticals, or combination products
• Familiarity with medical device risk management standards (e.g., ISO 14971 concepts)
• Prior involvement in New Product Development (NPD) environments
• Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles
• Clinical knowledge or experience supporting clinical risk assessment
• Experience using Minitab or other statistical analysis software
• Certification or experience with Design for Six Sigma / Design for Reliability methodologies
• Strong written, verbal, and digital communication skills
• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)

Qualifications

• Experience in medical devices, pharmaceuticals, or combination products
• Familiarity with medical device risk management standards (e.g., ISO 14971 concepts)
• Prior involvement in New Product Development (NPD) environments
• Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles
• Clinical knowledge or experience supporting clinical risk assessment
• Experience using Minitab or other statistical analysis software
• Certification or experience with Design for Six Sigma / Design for Reliability methodologies
• Strong written, verbal, and digital communication skills
• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)

Skills

• Strong written, verbal, and digital communication skills
• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)
• Certification or experience with Design for Six Sigma / Design for Reliability methodologies

Benefits

Salary ranges for U.S. (excl. PR) locations (USD): $79,200.00 - $118,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).