System Engineer

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 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)