Job Description

The SystemsVerification and Validation (V&V) Engineer 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. This role will lead the V&V effort with a Product V&V focus and will collaborate closely withEngineers, Architects, and Test in the Ventilation business to develop and commercialize medical devices.u00A0u00A0

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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.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

How we work together

We believe that we are better together than apart. This role is part of our officeu2011based team, requiring inu2011person collaboration at least three days per week in office.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

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System Verification & Validation Engineer