Sr. Post Market Quality Engineer

Medtronic • Lafayette, CO

3d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life As a Senior Post Market Quality Engineer where you'll play a pivotal role in driving quality excellence and continuous improvement. Reporting to the Post-Market Quality Director, you’ll lead trend analysis of complaints and quality data, conduct Product hold, field action activities, and manage quality improvement projects. Based in Colorado, this position offers the opportunity to work in a dynamic, innovative-driven environment where your analytical skills will directly impact product quality and patient safety. Responsibilities may include the following and other duties may be assigned. Maturing Post Market trending – the first year of this role will have a significant focus on improving trending processes and data analysis. 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.

Requirements

• Bachelor’s degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

Nice To Haves

• 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.

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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level