Philips System Testing Engineer 

Germany, Baden-Württemberg 

897450494

System Testing Engineer

You are responsible for

• Lead the verification activities for hardware and system testing of medical products.
• Develop, implement, and oversee test plans, test cases, and test reports to ensure product quality and compliance with medical standards and international regulations.
• Apply risk-based testing methodologies to ensure comprehensive coverage and prioritization of testing efforts.
• Analysis and post-processing of measurement data using statistical techniques.
• Prepare technical documentation in accordance with internal procedures and applicable medical device regulations/standards (per ISO 13485, 21CR820, and GDP)
• Collaborate with cross-functional teams to identify and troubleshoot hardware and system issues.
• Provide technical leadership and mentorship to other members of the testing team.
• Maintain up-to-date knowledge of medical standards, FDA requirements, and best practices in risk-based testing, MSA, and TMV.

To succeed in this role, you should have the following skills and experience

• Bachelor's or Master's degree in electronics/electrical engineering with a broad technical understanding and interest.
• Total of 7+ years of experience including 3+ years in electronics design (electronics development).
• In-depth knowledge of applicable medical standards (e.g., ISO 13485, IEC 60601) and FDA requirements for medical devices.
• In-depth knowledge I verification test (e.g., Mechanic, Packaging and Environmental Testing)
• Profound project management skills with a proven track record in leading multi-disciplinary verification projects
• Solid understanding of electronics and hands-on experience with hardware testing.
• Experience with risk-based testing, Measurement Systems Analysis (MSA), and Test Method Validation (TMV).
• Exceptional analytical, problem-solving, and communication skills.
• Demonstrated ability to guide and develop a team of hardware test engineers and good skills to manage projects.
• International mindset and willingness to work closely with other cultures and backgrounds

Language skills:

Speak and write English fluently

Good German skills desirable

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