System Engineer
Zimmerbiomet
- Bangalore, Karnataka
- Permanent
- Full-time
What You Can Expect:The Systems Engineer Complaint & Event Investigation is responsible for conducting rigorous, compliant investigations of product complaints, nonconformances, and adverse events to determine root cause, assess device and patient impact, and support regulatory decision-making. This role plays a critical role in post-market surveillance, MDR assessment, risk management linkage, and inspection readiness.
The position partners closely with Quality, Regulatory Affairs, Manufacturing, R&D, and Clinical teams and is especially suited to complex electromechanical or robotic medical devices.Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)How You'll Create ImpactComplaint & Event Investigation
- Conduct thorough investigations of complaints, nonconformances, and adverse events
- Determine root cause, contributing factors, and device performance impact
- Evaluate investigation data including complaint records, service data, manufacturing history, and design documentation
- Ensure investigations are completed accurately, thoroughly, and within required timelines
- Perform investigations in accordance with 21 CFR Part 820 (Quality System Regulation)
- Support 21 CFR Part 803 (Medical Device Reporting MDR) reportability assessments
- Provide investigation outputs that support regulatory submissions and health authority inquiries
- Ensure documentation meets FDA and internal quality expectations
- Assess patient safety, clinical risk, and device performance impact of reported events
- Link investigation outcomes to risk management activities per ISO 14971
- Support updates to risk files, hazard analyses, and risk controls based on post-market findings
- Collaborate with Quality, Regulatory Affairs, Manufacturing, R&D, Clinical, and Supplier Quality teams
- Facilitate cross-functional reviews to align on investigation conclusions and next steps
- Support escalation to CAPA, design changes, process improvements, or MDR reporting as required
- Produce clear, complete, and traceable investigation records
- Ensure documentation supports FDA inspections, internal audits, and management review
- Clearly document conclusions, rationale, and decision-making related to safety and compliance
- 4 to 6 years total experience in regulated medical device environments
- Experience investigating serious injuries, malfunctions, or death-related events
- Experience with robotic, software-driven, or capital medical equipment
- Experience collaborating with Clinical or Medical Affairs teams
- Quality or regulatory certifications (CQE, RAC, Six Sigma preferred)
- Strong analytical and systems-thinking skills
- High attention to detail and documentation rigor
- Ability to make defensible, risk-based decisions
- Clear communication with technical, clinical, and regulatory stakeholders
- Strong ownership for patient safety and compliance outcomes
- Experience in medical device systems engineering, quality engineering, or post-market surveillance
- 3+ years conducting complaint investigations or adverse event investigations in FDA-regulated environments
- Demonstrated experience supporting FDA inspections or regulatory audits
- Experience with complex electromechanical devices; robotic medical device experience preferred
- Electronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)
- Complaint handling and investigation workflows
- NCR, CAPA, and deviation management systems
- ISO 14971 risk management frameworks
- Hazard analysis, FMEA/FMECA, fault tree analysis (support level)
- Root cause analysis tools (5 Whys, Fishbone/Ishikawa)
- 21 CFR Part 820 (QSR)
- 21 CFR Part 803 (Medical Device Reporting)
- ISO 13485 (preferred)
- Post-market surveillance and vigilance processes
- Technical documentation systems (PLM, document control systems)
- Data analysis tools (Excel advanced; statistical tools preferred)
- EOE/M/F/Vet/Disability