Systems Engineer Norm Compliance

Job Title

Job Description

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:

• You are part of the Systems Engineering group in MR R&D
• You will work with colleagues around the globe, especially in India, US and China
• 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
• From a competitive salary to flexible working, a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about benefits in your region.

You're the right fit if you have:

• Bachelor's / Master's Degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent
• 5+ years of working experience in relevant areas such as systems engineering, research, development and/or test and verification
• Experience with complex, high-tech systems
• Experience in the medical device industry. Experience and knowledge of MRI systems will be considered a plus.
• Experience in the interpretation and implementation of medical standards in high-tech systems in a global environment
• Experience working directly with healthcare regulatory bodies and reporting to competent authorities on compliance with medical standards
• Experience in risk management of processes and implementations in a healthcare environment
• Experience in arranging a test program with testing laboratories in the medical device industry is a plus
• Strong analytical and accuracy skills, quality mindset with a continuous drive to improve
• 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).

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office role.

*This role is not open to a relocation.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

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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