\n You are part of Philips Medizin Systeme B\xc3\xb6blingen GmbH. We develop and produce patient monitoring systems for the global market. These are mainly used in emergency and intensive care medicine, pregnancy and newborn monitoring, surgery and anesthesia.

In this role, you have the opportunity to

be an integral part of a group of world-class Systems Test Engineers that ensure the high quality and standards compliance of our patient monitoring devices to help save lives all over the world.

• Developing reproducible and maintainable test methods for essential performance and particular standards tests according to the design input and standards requirements
• Coordination, execution and reporting of tests
• Prepare technical documentation in accordance with internal procedures and applicable medical device regulations/standards (per ISO 13485, 21CR820, and GDP)
• Work on the project deliverables related to Norm Compliance release evidence \xe2\x80\x93 Generate Technical File for CSA, EUMDR & NMPA certification.
• Providing the Regulatory Affairs department with technical support as preparation of submission to Regulatory bodies and countries
• Arranging and completing all evidence for gaining product certification by the independent certifying agency
• Collaborate and communicate effectively in cross-functional teams

• You have a Master or Bachelor in Bio-medical/Electrical/Electronics with 5+yrs of experience, preferably in Medical domain
• You have deep knowledge and Experience of relevant regulations (UL, CSA, IEC, GB etc.) and relevant standards (General Safety, EMI/EMC, Environmental etc.)
• You are familiar with global product safety and EMC standards (e.g. IEC 60601-1 and IEC 60601-1-2 and Collateral and Particular standards patient monitoring devices is preferable)
• You have knowhow of design control processes for medical device design
• You are a good team player and ability to work independently & act pro-actively
• You have a system thinking mindset and domain expertise in the related area
• You are structured and self-organized
• You have excellent communication skills \xe2\x80\x93 speak and write English fluently
• You have Intercultural sensitivity

A challenging and dynamic assignment in an organization that continuously strives to develop its talent. You will contribute to our mission to improve people\'s lives around the globe through meaningful innovation. We welcome you to a challenging, innovative environment with great opportunities for you to explore. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.\n \n \n \n \n \n

\n \n StepStone\n \n

\n