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
You will be successful if:
- You have a completed Master's or university degree in a technical field (such as Mechanical, Electrical, Software, or Systems Engineering).
- You have at least 5 years of experience in systems engineering or product safety risk management within the medical industry.
- You have in-depth knowledge of ISO 14971, ISO 13485, IEC 62366, and QMSR/FDA regulations.
- You have demonstrable experience with structured root-cause analysis methods such as FMEA, FTA, 5-Whys, and Fishbone.
Competenties
- Analytical skills: You quickly grasp dependencies within complex, multidisciplinary systems.
- Results orientation: You set clear priorities and complete safety dossiers in a timely, high-quality manner.
- Persuasiveness & communication: You clearly align interests with international and multidisciplinary stakeholders.
- Coaching skills: You guide and qualify colleagues to ensure a consistent standard in risk management.
- Quality awareness: You work accurately and in a structured manner, maintaining audit-ready documentation.
Arbeidsvoorwaarden
- A salary of up to €7,200 per month based on a 40-hour workweek.
- VvDN terms of employment.
- 25 vacation days for full-time employment.
- 8.33% holiday allowance.
- Pension scheme from day one.
- Travel allowance or the option of a public transport business card.
- Access to training and development opportunities via Randstad Academy.
Bedrijfsinformatie
About Philips:
Philips is a global leader in health technology, committed to improving people's health and well-being through meaningful innovation. The Best campus is a premier hub for Image Guided Therapy (IGT) systems, where multidisciplinary teams design and produce cutting-edge technology that enables physicians to perform precise, minimally invasive procedures.
Working through Randstad Professional:
We connect top-tier technical expertise with challenging, impactful projects at leading organizations like Philips. Through personal coaching, targeted development via the Randstad Academy, and a strong network of fellow professionals, we support you in taking the next strategic step in your engineering career.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Prithvi Vallabhoju
prithvi.vallabhoju@randstadprofessional.nl
010 808 3336
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