Complaint Investigation Engineer

Title: Complaint Investigation Engineer

Location: St. Paul, MN

Duration: 12 Months

100% Onsite

Summary

The Complaint Investigation Engineer is responsible for the technical evaluation and investigation of returned medical device products associated with customer complaints. This role performs detailed failure analysis, electrical and mechanical testing, root cause investigations, and technical documentation to determine the cause of reported product issues.

The engineer collaborates closely with Complaint Handling, Quality, R&D, Manufacturing, Supplier Quality, Reliability, and Regulatory teams to ensure investigations are scientifically sound, timely, and compliant with global quality system requirements.

The ideal candidate possesses a strong electrical engineering foundation, excellent analytical skills, and the ability to translate complex technical findings into clear, defensible investigation reports.

Key Responsibilities

Complaint Investigation

• Conduct comprehensive investigations of returned medical devices and associated components.
• Perform electrical, functional, mechanical, and visual evaluations of returned products.
• Develop investigation strategies based on complaint information, device history, and product design knowledge.
• Execute failure analysis activities to determine complaint validity and failure mechanisms.
• Differentiate between product-related, process-related, supplier-related, and user-related issues.

Root Cause Analysis

• Determine the most probable root cause using structured problem-solving methodologies.
• Support escalation activities when systemic or emerging trends are identified.

Technical Testing & Analysis

• Develop test plans to replicate field-reported failures.
• Utilize lab equipment including:
• Oscilloscopes
• Digital multimeters
• Data acquisition systems
• Environmental and functional test equipment
• Analyze product performance data and investigative test results.
• Interpret schematics, electrical designs, software logs, and manufacturing records.

Documentation & Compliance

• Document investigation activities and conclusions within complaint handling systems.
• Generate technically sound and audit-ready investigation reports.
• Ensure investigations meet established timelines and quality system requirements.
• Maintain complete, accurate, and traceable records supporting investigation conclusions.

Cross-Functional Collaboration

• Partner with Complaint Handling personnel to clarify customer-reported events.
• Work with R&D and Manufacturing Engineering to evaluate potential design or process issues.
• Collaborate with Quality Engineering and CAPA teams when investigations indicate systemic concerns.
• Present investigation results to leadership and regulatory auditors as required.

Continuous Improvement

• Identify recurring failure modes and emerging complaint trends.
• Contribute to corrective and preventive actions (CAPA).
• Recommend product, process, or supplier improvements based on investigation outcomes.
• Support development of standard investigation methods and laboratory capabilities.

Required Qualifications

Education

• Bachelor's degree in Electrical Engineering, Electronics Engineering, Biomedical Engineering, or a related engineering discipline.

Experience

• Experience performing root cause investigations and technical failure analysis.
• Experience working within regulated quality systems.

Technical Skills

• Strong understanding of electrical systems and troubleshooting techniques.
• Ability to read and interpret:
• Electrical schematics
• Wiring diagrams
• Technical specifications
• Test protocols
• Experience with laboratory diagnostic equipment.
• Strong technical writing and documentation skills.
• Proficiency with Microsoft Office and data analysis tools.

Preferred Qualifications

• Medical device industry experience.
• Experience investigating field complaints and returned products.
• Knowledge of:
• FDA Quality System Regulations
• ISO 13485
• Risk Management principles
• CAPA processes
• Experience with electromechanical systems, ablation systems, generators, catheters, or implantable medical devices.
• Prior experience supporting audits and regulatory inspections.

Core Competencies

• Technical curiosity
• Structured problem solving
• Root cause investigation
• Attention to detail
• Data-driven decision making
• Written communication
• Laboratory troubleshooting
• Collaboration and influence
• Regulatory compliance mindset

Success Measures

The successful candidate will:

• Deliver timely and high-quality complaint investigations.
• Effectively identify and document root cause.
• Reduce investigation cycle time while maintaining quality.
• Identify meaningful trends and systemic issues.
• Provide clear, defensible technical conclusions that withstand regulatory and audit scrutiny.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.