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Randstad professional logo Senior Systems Engineer - Safety & Risk Management Koninklijke Philips N.V. - Best - Detachering - HBO - 40 uur - € 6.750 per maand - Bewaar vacature Prithvi Vallabhoju [email protected] 010 808 3336 [email protected] 010 808 3336 As a Senior Systems Engineer - Safety & Risk Management at Philips in Best, you safeguard patient well-being during high-impact minimally invasive medical procedures. You drive end-to-end product safety and quality across image-guided therapy systems, transforming field insights into compliant engineering solutions. Philips relies on advanced engineering to ensure their Azurion and Allura medical systems perform safely and seamlessly in critical clinical environments. In this role, you take full ownership of risk management across the entire product lifecycle-from initial development and sustaining engineering to post-market surveillance. Working closely with cross-functional teams in Best and Bangalore, you evaluate field signals, perform rigorous risk analyses, and ensure strict compliance with international medical device standards. • Lead safety risk management and CAPA investigations for Azurion and Allura medical platforms. • Perform structured root-cause analysis (FMEA, FTA, 5-Whys, Fishbone) to link failure modes to potential patient harm. • Translate system logs, complaint data, and replacement rates into actionable risk insights. • Author and finalize audit-ready post-market risk reviews, safety rationales, and regulatory assessments. • Collaborate cross-functionally with R&D, Quality, Service, and Regulatory teams to drive risk-mitigation measures to closure. Functie-eisen Jij bent succesvol als: • Je een afgeronde master- of wo-opleiding hebt in een technische richting (zoals Mechanical, Electrical, Software of Systems Engineering). • Je minimaal 5 jaar ervaring hebt met systems engineering of prod...



