Complaints Engineer

Role: Complaints Engineer

Location: Arden Hills, MN

Duration: 6 Months

Industry: Medical Device

Position Summary

The Complaints Engineer will lead technical complaint investigations and escalation activities for a range of Interventional Cardiology (IC) medical devices. This role is responsible for post-market surveillance, complaint investigations, root cause analysis, CAPA, and NCEP activities to identify, investigate, and resolve product safety and quality issues. The position requires strong cross-functional collaboration with Quality, Engineering, R&D, Regulatory, Manufacturing, and Post-Market teams.

Key Responsibilities / Job Duties

• Lead technical complaint investigations and escalation activities for Interventional Cardiology (IC) medical devices.
• Analyze post-market surveillance data, including product complaints and adverse events, to identify potential safety and quality issues.
• Conduct detailed complaint investigations and document investigation findings within the applicable Quality Management System (QMS).
• Lead Root Cause Analysis (RCA) for escalated product complaints, product signals, and quality issues.
• Own and manage assigned CAPA and NCEP activities through investigation, implementation, and closure.
• Evaluate product performance and identify trends, recurring issues, and potential product quality signals.
• Present product performance insights, complaint trends, and investigation findings to leadership and design teams.
• Support the preparation and development of published product performance reports and post-market quality documentation.
• Provide technical guidance and mentorship to product investigators on complaint investigation activities.
• Utilize and coordinate investigative and analytical equipment, including X-Ray, FTIR, and SEM, as required for technical investigations.
• Apply statistical methods and analytical techniques to support complaint investigations and product performance evaluations.
• Partner with Quality, Engineering, R&D, Regulatory, Manufacturing, and Post-Market organizations to resolve product quality issues.
• Support continuous improvement initiatives across local and global Post-Market Quality teams.
• Ensure complaint investigations and quality activities are completed in accordance with applicable medical device regulations, procedures, and quality-system requirements.
• Maintain accurate and complete investigation records, technical documentation, and quality-system records.
• Identify opportunities for process improvements based on complaint trends, investigation outcomes, and post-market data.

Required Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical/scientific field.
• Experience with medical device complaint investigations and post-market quality activities.
• Experience performing Root Cause Analysis (RCA) and technical investigations.
• Experience with CAPA and/or NCEP processes.
• Strong analytical, technical, and problem-solving skills.
• Ability to apply statistical methods and data analysis techniques when appropriate.
• Strong written and verbal communication skills.
• Demonstrated ability to influence and collaborate effectively with cross-functional teams.

Preferred Qualifications

• Knowledge of ISO 13485 and medical device Quality Management Systems.
• Knowledge of FDA Quality System Regulation (QSR).
• Knowledge of Medical Device Reporting (MDR) requirements.
• Experience with Post-Market Surveillance (PMS) and complaint trending.
• Experience with CAPA and NCEP processes.
• Experience with investigative and analytical equipment such as X-Ray, FTIR, and SEM.
• Experience in Interventional Cardiology or other medical device product areas.
• Experience working with Quality, Engineering, R&D, Regulatory, Manufacturing, and Post-Market functions.