System Engineer in Bangalore, भारत

Zimmer Biomet seeks a Systems Engineer in Bangalore to investigate product complaints, adverse events, and nonconformances in medical devices. The role ensures regulatory compliance, assesses patient safety impact, and supports post-market surveillance and FDA inspections through rigorous root-cause analysis and cross-functional collaboration.

Responsibilities

• Conduct thorough investigations of complaints, nonconformances, and adverse events to determine root cause
• Assess patient safety, clinical risk, and device performance impact of reported events
• Ensure investigations comply with FDA regulations and internal quality standards within required timelines
• Collaborate with Quality, Regulatory Affairs, Manufacturing, R&D, and Clinical teams on investigation conclusions
• Produce clear, traceable investigation documentation supporting FDA inspections and regulatory submissions

Requirements

• 3+ years conducting complaint or adverse event investigations in FDA-regulated medical device environments
• Experience with complex electromechanical or robotic medical devices
• Proficiency with electronic quality management systems and complaint handling workflows
• Knowledge of 21 CFR Part 820, 21 CFR Part 803, and ISO 14971 risk management
• Strong analytical skills, attention to detail, and technical documentation capability
• Experience supporting FDA inspections or regulatory audits
• 4-6 years total regulated medical device environment experience preferred