Medtronic · 10 hours ago
Senior Principal Quality Engineer - Minneapolis
Minneapolis, MN
Full-time
Onsite
Senior Level, Lead/Staff
$147K/yr - $221K/yr
8+ years expMedtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. They are seeking a Senior Principal Quality Engineer to lead the development and implementation of post-market surveillance programs, ensuring product quality and safety through collaboration with cross-functional teams and compliance with global regulations.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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
Qualification
Required
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
Preferred
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
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.
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
BioWorld Financial Watch
2026-01-25
Company data provided by crunchbase