Quality Engineer II, Post Market Surveillance

Medtronic•Lafayette, CO

About The Position

As a Post Market Quality Engineer II where you'll play a pivotal role in driving quality excellence and continuous improvement. Reporting to the Post-Market Quality Director, you will be working with the post market team on analysis of complaints and quality data, Health Risk Assessments, 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.

Requirements

Bachelor’s degree required
Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 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)