Hybrid Senior Principal Quality Engineer

at Medtronic

• Job title: Senior Principal Quality Engineer
• Job type: Full Time
• Experience level: Senior
• Salary: $147,200 - $220,800 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Minneapolis, United States

About the role

• Risk Management Expert leading risk management strategies for medical device products at Medtronic. Ensuring regulatory compliance and product safety through effective risk mitigation.

Responsibilities

• Lead risk management strategy for our medical device products
• Create and manage risk management plans and reports, as well as conduct regular risk reviews
• Perform thorough hazard analyses to identify potential risks and implement effective mitigation measures
• Lead Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams
• Analyze and review product complaints to anticipate and prevent future issues
• Conduct detailed risk analyses in conjunction with the system engineering team
• Implement and maintain robust product security measures
• Develop and manage post-market surveillance plans to monitor product performance and safety
• Maintain and curate risk logs

Requirements

• Bachelor’s degree in Engineering, or a related technical field
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards
• Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis
• Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders
• Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously
• Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred
• Experience in Quality Assurance, Engineering, Capital equipment Industry Experience: Medical device industry
• Proficient in quality assurance practices, risk management, and regulatory compliance.

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
• 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)