Senior Systems Engineer MR: NMPA

Senior Systems Engineer MR: NMPA

As a Senior Systems Engineer for NMPA in the Philips MR business, you will ensure that the submission process of the MR-products for the local market in China is optimal ensuring fast throughput time and alignment with global product development. You will do this by ensuring that the technical content of the submission package is aligned with the needs from NMPA. Alignment with the global MR R&D organization is key to achieve this.

Being part of the MR R&D team in Suzhou, this team of high-level technical engineers is responsible for design of components which are used for MR Systems developed worldwide as well as for the introduction and maintenance of the locally produced MR Systems for the Chinese market.

Being located in Suzhou, Jiangsu in China, you are requested to frequently travel to the Philips office in Best, The Netherlands (current design owner of the MR Systems in scope) and potentially other Philips MR R&D locations in India and United States. This to ensure optimal alignment of the development process in the global MR R&D locations with the NMPA submission process.

Reporting to the R&D HW Development / MR R&D Suzhou Site Leader in Suzhou with a dotted line to the System Engineering Group leader of MR R&D Best.

Providing thorough understanding of NMPA standards and regulations for MR medical devices.

Supporting the NMPA certification process by translating details of the NMPA standards and regulations, as well as supplemental notices to the global R&D departments and (co-)generation of appropriate documentation.

Guidance towards the global R&D team in translation of the MR NMPA standards and regulations into requirements, design and implementation.

Supporting life cycle management, complaint investigations and post market surveillance activities specifically related to NMPA standards and regulations for MR medical devices.

Driving improvements in NMPA Submission process to embed the NMPA Submission process in global New Product Development process in an efficient way to ensure that worldwide product introductions are done in the most efficient way.

You're the right fit if:

• At least a Master's degree in physics, electronic engineering or mechanical engineering
• Good communication skills in Chinese and English
• Ability to collaborate in a global cross-functional team and experience in creating alignment between broad varieties of stakeholders (internal and external).
• Sensitive for cultural differences between China, Europe, US and India. Proven working experience in Europe and China.
• 5-year experience in high tech (system) engineering, like research, development or test and verification. Experience and knowledge with MRI systems is a pre.
• Experience in interpretation and implementation of medical standards in high tech systems in a global environment.
• Strong analytical skills, with high quality output.
• Very accurate and quality minded with a continuous drive to improve.
• Helicopter view with ability to good deep into the technical content.
• Proven skills in understanding complex products and it's documentation structure.
• Experience in NMPA standards and regulations as well as the differences with global standards. Hands-on experience with global submissions (e.g. EU-MDR, FDA and NMPA) is a pre.
• Understanding Risk Management processes and implementations in a medical environment.
• Experience in reporting to competent authorities on compliance with medical standards.
• Experience in defining and arranging tests in the context of the medical standard is a pre.

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