Medtronic · 22 hours ago
Sr. Post Market Quality Engineer
Lafayette, Colorado, United States of America
Full-time
Onsite
Mid, Senior Level
$97K/yr - $145K/yr
4+ years expMedtronic is a leader in global healthcare technology, committed to solving the most challenging health problems. In this role as a Senior Post Market Quality Engineer, you will drive quality excellence and continuous improvement by analyzing data, assessing health risks, and ensuring regulatory compliance to enhance product quality and patient safety.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Monitor Product Performance: Collect and analyze data from various sources (complaints, adverse events, clinical follow-up, literature) to identify product issues and trends
Data Analysis: Conduct trending and risk analysis on post-market data to detect potential safety or performance issues
Health Risk Assessment: Conduct and document Health Risk Assessments (HHA) to evaluate the potential impact of product issues on patient safety and recommended actions
Regulatory Compliance: Ensure all activities comply with FDA, EU MDR, ISO 13485, and other applicable regulations
Continuous Improvement: Recommend and support corrective and preventive actions (CAPA) based on post-market findings
Collaboration: Work closely with Regulatory, Quality, R&D, and Manufacturing teams to address product safety and performance concerns
CAPA: Participate in CAPA investigations and determination of appropriate corrective actions
Review of Clinical Performance: Participate in review and documentation of clinical performance of devices (Periodic Safety Update Report, Post-Market Clinical Follow up, and Clinical Evaluation Reports
Documentation: Maintain accurate and thorough records of all post-market surveillance activities
Qualification
Required
Bachelor's degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
Preferred
Experience in quality data analysis and trending in medical device industry
Experience in Post Market Surveillance and/or Risk Assessment
Strong statistical analysis skills and proficiency with tools like Minitab, JMP, or Excel advanced functions
Knowledge of medical device regulations: FDA 21 CFR Part 820, ISO 13485, MDR/IVDR
Knowledge of global post-market surveillance regulations and standards (e.g., FDA 21 CFR 820, EU MDR, ISO 14971)
Experience with CAPA processes and root cause analysis methodologies (5-Why, Fishbone, 8D)
Strong analytical, communication, and problem-solving skills
Project management experience with quality improvement initiatives
Experience with quality management software (TrackWise, GCH, or similar)
Excellent analytical and problem-solving skills with attention to detail
Ability to manage multiple projects simultaneously
Self-motivated with ability to work independently and drive initiatives to completion
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