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 Senior Systems Engineer Complaint Investigation & Regulatory Compliance leads complex, high-risk investigations of medical device complaints to ensure timely, thorough, and compliant evaluations in accordance with 21 CFR Part 820.198. This role performs deep technical and clinical analyses to identify root causes and systemic issues, supports Medical Device Reporting (MDR) determinations under 21 CFR Part 803, and ensures alignment with ISO 14971 risk management.
The role partners closely with Quality, Regulatory Affairs, R&D, Manufacturing, Clinical, and Field Service 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 Impact
Regulatory-Compliant Investigation
- Lead and execute complaint investigations in compliance with 21 CFR Part 820.198
- Ensure investigations are timely, complete, and well-documented, meeting internal and regulatory timelines
- Synthesize evidence from complaints, service data, manufacturing history, design documentation, and clinical inputs
Root Cause Determination
- Perform advanced technical and clinical analyses to identify failure modes, contributing factors, and potential systemic issues
- Apply structured root cause methodologies (e.g., 5 Whys, Fishbone, Fault Tree)
- Differentiate between isolated events and trends requiring escalation (e.g., CAPA, design changes)
MDR Reportability Assessment
- Support evaluation of complaints for MDR reportability in accordance with 21 CFR Part 803
- Document clear, defensible reportability decisions and rationale
- Partner with Regulatory Affairs to ensure consistent interpretation and timely submissions when required
Risk & Patient Safety Assessment
- 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
Documentation & Audit Readiness
- Maintain complete, accurate, and traceable investigation records
- Ensure documentation is inspection-ready for FDA inspections, internal audits, and management review
- Present investigation conclusions, trends, and recommendations to cross-functional and leadership audiences
What Makes You Stand Out
Preferred Qualifications
- 7 to 10 years total experience in regulated medical device environments
- Experience investigating serious injuries, malfunctions, or death-related events
- Experience collaborating with Clinical/Medical Affairs on safety assessments
- Experience with robotic, software-driven, or capital equipment
- Quality or regulatory certifications (CQE, RAC, Six Sigma preferred)
Core Competencies
- Strong systems thinking and analytical rigor
- High documentation discipline and audit readiness
- Ability to make defensible, risk-based decisions
- Clear communication with technical, clinical, and regulatory stakeholders
- Ownership mindset for patient safety and compliance outcomes
Your Background
Required Technical Skills
- 710 years of experience in medical device systems engineering, quality engineering, or post-market surveillance
- 4+ years leading complaint 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, investigation, NCR, and CAPA workflows
Service and manufacturing data systems (traceability, DHR/DHF access)
Risk Management & Analysis
ISO 14971 risk management frameworks
Hazard analysis, FMEA/FMECA, fault tree analysis
Root cause analysis tools (5 Whys, Fishbone/Ishikawa)
Regulatory & Standards
21 CFR Part 820.198 (Complaint Handling)
21 CFR Part 803 (Medical Device Reporting)
ISO 13485 (preferred)
Post-market surveillance and vigilance processes
Data, Reporting & Documentation
Advanced Excel; statistical or BI tools (Power BI/Tableau preferred)
Document control and PLM systems
Technical documentation and controlled records management
Education And Experience Requirements
Bachelor's degree in systems engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related technical field (or equivalent experience)
EOE/M/F/Vet/Disability
