System Verification and 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. 

• 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.  

• 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. 

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. 

• 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 organizational value. Maintaining strict confidentiality of sensitive information.