Senior Systems Engineer - Safety & Risk (IGT)

randstad professional; Best; On-site; EUR 69,000 - 82,000; Full time

Benefits offered by this job

25 vacation days

Pension from day 1

Commuting allowance or OV-card

Randstad Academy access

Job summary

Philips in Best seeks a Senior Systems Engineer - Safety & Risk Management to safeguard patient well-being during high-impact minimally invasive procedures. You own risk management across the lifecycle and translate field insights into compliant engineering solutions for image-guided therapy systems.

You will lead risk analyses, ensure compliance with ISO 14971/13485, IEC 62366, and drive post-market surveillance with teams in Best and Bangalore.

Qualifications

• Master's or postgraduate degree in a technical field (Mechanical, Electrical, Software or Systems Engineering).
• Minimum 5 years of experience in systems engineering or medical device safety risk management.
• Strong knowledge of ISO 14971, ISO 13485, IEC 62366 and QMSR/FDA regulations.
• Experience with structured root-cause analyses such as FMEA, FTA, 5-Whys and Fishbone.

Responsibilities

• Lead safety risk management and CAPA investigations for Azurion and Allura platforms.
• Perform structured root-cause analyses (FMEA, FTA, 5-Whys, Fishbone).
• 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.

Skills

Analytical thinking

Results oriented

Communication

Coaching

Quality mindset

Education

Master's or MSc in Mechanical, Electrical, Software or Systems Engineering

Tools

FMEA

FTA

5-Whys

Fishbone

Job description

Philips in Best seeks a Senior Systems Engineer - Safety & Risk Management to safeguard patient well-being during high-impact minimally invasive procedures. You own risk management across the lifecycle and translate field insights into compliant engineering solutions for image-guided therapy systems.

You will lead risk analyses, ensure compliance with ISO 14971/13485, IEC 62366, and drive post-market surveillance with teams in Best and Bangalore.