Medtronic · 1 day ago
Sr Prin Quality Engineer
Minneapolis, MN
Full-time
Onsite
Senior Level, Lead/Staff
$147K/yr - $221K/yrMedtronic is a global healthcare technology company committed to alleviating pain and restoring health. They are seeking a Sr Prin Quality Engineer to lead risk management strategy for medical device products, ensuring product safety and regulatory compliance throughout the product lifecycle.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Develop and maintain comprehensive strategies for risk management activities, including:
Creating and managing risk management plans and reports, as well as conducting regular risk reviews
Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures
Leading Failure Modes and Effects Analyses (FMEAs) 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
Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed
Implementing and maintaining robust product security measures to protect against potential vulnerabilities
Developing and managing post-market surveillance plans to monitor product performance and safety in the field
Maintaining and curating risk logs to ensure accurate and up-to-date risk documentation
Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards
Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle
Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections
Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements
Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports
Qualification
Required
Education: Bachelor's degree in Engineering, or a related technical field. Advanced degree preferred
Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards
Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis
Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders
Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously
Preferred
Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred
Experience: Experience in Quality Assurance, Engineering, Capital equipment
Industry Experience: Medical device industry
Technical Skills: 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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
Founded in 1949
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase