System Engineer
Zimmer Biomet · Bengaluru
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
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)
Shift Timing - 11:00 AM - 8:00 PM
How You'll Create Impact
Complaint & 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
FDA Regulatory Compliance
- 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
Risk & Patient Safety Evaluation
- 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
Cross-Functional Coordination
- 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
Documentation & Inspection Readiness
- 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
What Makes You Stand Out
Preferred Qualifications
- 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)
Core Competencies
- 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
Your Background
Required Technical Skills
- 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
Technologies & Tools
Quality & Investigation Systems
- Electronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)
- Complaint handling and investigation workflows
- NCR, CAPA, and deviation management systems
Risk Management & Analysis
- ISO 14971 risk management frameworks
- Hazard analysis, FMEA/FMECA, fault tree analysis (support level)
- Root cause analysis tools (5 Whys, Fishbone/Ishikawa)
Regulatory & Standards
- 21 CFR Part 820 (QSR)
- 21 CFR Part 803 (Medical Device Reporting)
- ISO 13485 (preferred)
- Post-market surveillance and vigilance processes
Data & Documentation
- Technical documentation systems (PLM, document control systems)
- Data analysis tools (Excel – advanced; statistical tools preferred)
EOE/M/F/Vet/Disability
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