Hybrid Quality Engineer II – Risk Management, New Product Development

at Medtronic

• Job title: Quality Engineer II – Risk Management, New Product Development
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: $76,800 - $115,200 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Lafayette, United States

About the role

• Quality Engineer II supporting Risk Management activities for New Product Development within robotics portfolio at Medtronic. Contributing to patient safety and compliance with FDA standards while collaborating across teams.

Responsibilities

• Serve as the risk management subject matter contributor on assigned New Product Development programs
• Assess potential patient and user risks associated with products under development
• Develop, update, and maintain risk management documentation, including: Hazard analyses, Risk assessments (e.g., URRA / user risk reliability assessments), Risk controls and verification activities
• Incorporate FDA feedback and evolving regulatory expectations into risk documentation across programs
• Collaborate with the program’s Quality Core Team Member (QCTM) and broader cross‑functional core teams
• Support ongoing updates to quality system documents and procedures related to risk management
• Contribute to process improvements and special quality projects as needed
• Communicate risk‑related impacts clearly across multidisciplinary stakeholders

Requirements

• Bachelor’s degree in Engineering or a related technical field plus 2 years of applicable experience, OR Master’s degree in Engineering or a related field with 1+ year of applicable experience
• Hands-on experience with risk analysis and risk management within a regulated industry
• Technical background in both mechanical and electromechanical systems
• 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)
• Authorization to work in the United States without the need for future visa sponsorship.

Benefits

• 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
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• 401(k) plan plus employer contribution and match
• 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)