Senior Systems Engineer – Safety & Risk Management

Senior Systems Engineer – Safety & Risk Management

Job description

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.