Senior System Engineer

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

• 7–10 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)