Engineer - Complaints Technical Investigator

About the role

We are looking for an Engineer – Complaints Technical Investigator to join our Complaints Trending and Investigation group. The role focuses on forensic evaluation of returned medical device units, root cause analysis, and development of corrective actions to improve product quality and patient experience.

Key responsibilities

• Lead evaluation of returned products, reserve samples, batch records, and complaint histories.
• Provide engineering input for product improvements and develop structured failure‑analysis processes.
• Conduct root cause analysis using fishbone diagrams, 5 Whys, FMEA, Fault Tree Analysis, tolerance analysis, and specialized equipment such as CT scanners, Instron tensile testers, and SEM.
• Collaborate with cross‑functional teams to design solutions that reduce complaints and create business plans for implementation.
• Generate final investigation reports, including data collection and statistical analysis.
• Set up investigation lab equipment, develop and validate test methods, train personnel, and write SOPs.

Required profile

• Master’s degree in a scientific discipline (preferred).
• 5+ years of experience in complaints handling or failure analysis within a medical‑device development or manufacturing environment.
• Demonstrated experience with Six Sigma methodologies and risk management per ISO 14971.
• Strong technical writing and interpersonal communication skills.

Required skills

• Protocol and report writing
• Process and test development and execution
• Design of experiments (DoE)
• Root cause analysis tools: fishbone diagrams, 5 Whys
• Risk analysis methods: FMEA, Fault Tree Analysis, tolerance analysis
• Six Sigma proficiency
• Risk management per ISO 14971
• Use of CT scanners, Instron tensile testing machines, Scanning Electron Microscope (SEM)