System Test Engineer

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About the role

Job Title System Test Engineer Job Description The Systems Test Engineer (Product V&V (Verification and Validation)) will be a part of the Engineering group that is responsible for implementing technical strategies, evaluate and develop products, and provide a superior level of technical support that benefits the organization. The Systems Test Engineer will lead the V&V effort / with a Product V&V focus collaborates closely with Engineers, Architects, and Test in the Ventilation business to develop and commercialize Class 2 medical devices. Your role: • Works together to support product verification and validation planning, resolution of technical integration issues, safety agency interface, system testing and coordination and interfaces with Philips design center. • Provides engineering expertise in software and system verification and establishes system V&V plans, assists in developments of protocols and reviews reports. • Implements design for testability by collaborating with R&D (Research and Development) teams to evaluate requirements for testability. Collaborates with external agencies for compliance and safety certification • Incorporates essential operating mechanisms of systems engineering of medical device design and engineering principles and adheres to medical device regulations. • Defines system requirements, architecture, and interfaces to meet product requirements, risk analysis and industry standards; conducts system design analysis to select key components and defines control methods; and coordinates build and design integration. • Conducts design reviews as part of the product development process to ensure customer requirements are met and the designs are manufacture-able, serviceable, and reliable. In addition, it does the same for subsystem requirements and product integration. You're the right fit if: • Bachelor's /Master's degree in electrical engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering OR Vocational Education in Information Technology or equivalent. • 3-5 years of experience successfully developing complex medical devices (hardware, software, consumables) products for acute care/hospital markets is necessary.  • Hands-on experience (technical) in ventilation is a plus.  • Knowledge of Statistical Data Analysis is necessary. Includes ability to critically evaluate proposed study designs with basic knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power.  • Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolutions   • Solid understanding of System Verification and Validation test plan/protocols , executing V&V activities, generating, and analyzing test reports • Exposure to automation, Understanding of lab setup, qualification & equipment usage • Understanding of global medical device regulatory environments and clearance processes.  • Effective communication, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team.  • Experience auditing a DHF (Design History File - a compilation of records which describe the design history of a finished device) for compliance with internal processes and external standards.  • Ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.  • Data-driven decision-making : ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues. • Relentless focus on Quality and Transparency as an organizationa

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