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As a System Engineer Norm Compliance, you will ensure our products meet medical standards by managing life cycle activities, investigating complaints, and conducting post-market surveillance.
Your role:
Support life cycle management, complaint investigations and post-market surveillance activities related to applicable medical standards/regulations.
Provide a deep understanding of IEC60601-1 series of medical standards and its translation into requirements, design, and implementation
Support regulatory activities to comply with applicable medical standards/regulations.
Create Test Report Forms (TRF) with proof of compliance to clauses of the applicable standards.
Support the certification process. Contribute to managing the certification bodies. Contribute to quality and process improvements in this area.
Drive, manage, and contribute to improvement activities in the generation of Test Report Forms.
Drive improvements in design in relation to the applicable medical standards/regulations.
You're the right fit if you have :
A Bachelor’s Degree in Electronic Engineering
Minimum of 5 years of experience in high-tech (system) engineering, like research, development, or test and verification
Experience in the interpretation and implementation of medical standards in high-tech systems in a global environment.
Experience with specific healthcare regulations and regulatory bodies especially related to IEC60601-1 and it's appendices.
Experience in reporting to competent authorities on compliance with medical standards.
Understanding Risk Management processes and implementations in a medical environment.
Experience in arranging a test program (related to medical standards) by a component laboratory.
Strong analytical skills, with high-quality output
Good communication skills and ability to collaborate in a cross-functional team and experience in creating alignment between broad varieties of stakeholders (internal and external).
Very accurate and quality-minded with a continuous drive to improve.
Advantages :
Experience in defining and arranging tests in the context of the medical standard
Experience and knowledge of MRI systems
About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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