System Verification & Validation Engineer

• 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.u00A0

• Providesengineering expertise in software and system verification and establishes system V&V plans, assists in developments of protocols and reviews reports.u00A0

• 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 certificationu00A0

• Incorporates essential operating mechanisms of systems engineering of medical device designand engineering principles and adheres to medical device regulations.u00A0

• 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.u00A0

• 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.u00A0u00A0

• The systems team drives the systems elements of R&D development projects including systems requirement definition and management, architectural definition, control/software/interface product specification and simulation, build integration, system testing and qualification to meet product level requirements.u00A0

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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.

• 6+ years of experience successfully developing complex medical devices (hardware, software, consumables) products for acute care/hospital markets is necessary.u00A0

• Hands-onexperience (technical) in ventilation is a plus.u00A0

• Knowledge ofStatistical 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.u00A0

• Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolutionsu00A0u00A0

• 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.u00A0

• Effective communication, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team.u00A0

• 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.u00A0

• Ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.u00A0

• 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 organizational value. Maintaining strict confidentiality of sensitive information.u00A0