System Engineer
Zimmer Biomet · Bangalore, India
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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