Senior Systems Engineer – Safety & Risk Management

Senior Systems Engineer – Safety & Risk Management at Philips. As a Senior Systems Engineer specializing in Safety Risk Management, you will work on product safety for our Image Guided Therapy (IGT) Systems – Azurion and Allura platforms. You will support new product introductions, sustaining engineering, and post-market surveillance, ensuring that patients can undergo acute, minimally invasive procedures on systems designed and maintained according to state-of-the-art safety and reliability concepts.

Your expertise will be central to how IGT-S investigates, evaluates and resolves field and quality signals, ensuring that every assessment is grounded in ISO 14971 and Philips risk-management policy. You will work in close partnership with R&D, Quality, Service, Post-Market Surveillance, Regulatory and Medical, as well as the IGT-S R&D Excellence CAPA pool based in Bangalore.

Your role: Lead and execute product-safety risk management activities for assigned Azurion and Allura topics across the full lifecycle (NPI, sustaining, post-market surveillance). Depending on organizational needs, act as CAPA Owner and drive execution of the CAPA process, including root-cause investigation, action planning, implementation, effectiveness verification and closure. Author, review and drive to closure post-market risk reviews, safety rationales and risk assessments that underpin CAPA investigations, field actions and complaint trending decisions.

Provide risk-management/ CAPA owner leadership into CAPA investigations: define hazardous situations, link failure modes to harm, evaluate severity/occurrence, and contribute to root-cause analysis and effectiveness verification (FMEA, FTA, 5-Whys, Fishbone, etc.). Own assigned safety-risk deliverables end-to-end, balancing quality, completeness, audit-readiness and timelines. Translate complaint data, system logs, installed-base data and replacement rates into risk-based insights and decisions, in close collaboration with CAPA Owners, Quality, R&D and Post-Market Surveillance.

Lead cross-functional alignment on corrective and preventive actions from a safety perspective: define hazardous-situation impact, agree risk-control measures, timelines and responsibilities, and escalate implementation risks. Maintain and advance Philips' safety risk management and system engineering practices (procedures, templates, training material, author qualification) in line with QMSR, ISO 14971, ISO 13485 and FDA expectations. Generate clear status, trend and metric reporting on safety risk deliverables to management and governance bodies.

Coach and align stakeholders – including authors, reviewers and engineering leads – to ensure consistent, high-quality risk-management deliverables across the global footprint of the R&D organization. You're the right fit if you have: Master’s degree in an engineering discipline (Mechanical, Electrical, Software, Systems, or equivalent); a PhD is preferred. Minimum 5+ years of experience in systems engineering and/or product-safety risk management in a medical-device regulated industry.

Strong working knowledge of ISO 14971, ISO 13485, IEC 62366, FDA QSR/QMSR and post-market surveillance requirements. Proven experience with risk-management content in investigations, field actions and CAPA-type processes, including structured problem solving and root-cause analysis (FMEA, FTA, 5-Whys, Fishbone). Very strong analytical skills and the ability to understand dependencies within a complex, multi-disciplinary system. Demonstrated ability to drive assigned (safety-risk) deliverables to closure, balancing quality, compliance and timelines (project-management mindset).

Data-analytics literacy and the ability to derive meaningful insights from complaint data, system logs, installed-base data and replacement rates to derive risk-based insights. Excellent documentation and writing skills, with the ability to produce clear, compliant rationales, reports and audit-ready records. Strong communication and stakeholder-management skills, including the ability to work effectively with geographically distributed, multicultural team and with regulatory bodies.

Experience supporting audits by competent authorities or notified bodies; certification relevant to risk management or quality is a plus. A continuous-improvement and coaching mindset, with the ability to qualify and develop authors and reviewers.

How we work together: This is an office-based role; for our office-based teams this means working in-person at least 3 days per week at our Best campus.