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.

• 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.

Youre the right fit if:

• Bachelors /Masters 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 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.