System Engineer

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

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

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

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