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You will be involved in all system engineering aspects of the Philips V-model, starting with conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally the validation. In your role, you will support system architects and engineers to integrally manage all system engineering aspects in a model-based way supported by the appropriate tools. You will maintain and develop knowledge and expertise resulting in state-of-the-art approaches to serving our customers.
You will be involved and expected to lead Sustenance, FDA Remediation systems engineering projects. Hence, experience in Sustenance, FDA remediation systems engineering would be preferred.
In addition, only on specific project need basis, you will lead the systems engineering aspects of Model Based Systems Engineering (MBSE). Please note that Sustenance & Remediation projects typically do not require MBSE. As System Engineering Expert and on specific project need basis – you are responsible for the process, method, and tools in the context of model-based system engineering (MBSE) within projects of the Philips businesses globally utilizing the MBSE Modelling tools like Cameo. These projects can cover every phase of the product life cycle, from development, manufacturing, market deployment, operation, and maintenance to phase out. You will also help to deploy capabilities throughout the global company by providing training and coaching to system engineers and system architects.
Your role:
Incorporates essential operating mechanisms of systems engineering of medical device design and engineering principles and adheres to medical device regulations.
Defines User Requirements, system requirements, FMEA, 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
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.
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.
As a System Engineering Expert, you will:
Lead and Support the development of System engineering content in R&D (Research and Development) projects across the business.
Manage the system engineering information and its traceability (requirements, risks, design decisions, protocols, results) in the model-based system environment of the business
Create adequate requirements and designs for solutions, products, services, and testers
Deploy best system engineering practices globally in Philips to R&D project teams or organizations via training & coaching to enhance maturity
Identify improvement opportunities in Philips businesses proposition and develop actionable proposals, plans and tailored training materials or workshops to address these
Manage your activities and services according to good project management practices
Coordinate small teams of system engineers if applicable
The ability to make things happen by encouraging and channeling the contributions of others; recognizing and addressing critical issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results.
Accountability/Ownership: Work closely with team members and take ownership – be a mentor to junior engineers
Influence: The demonstrated ability to gain acceptance and commitment from others to one’s own beliefs and ideas.
Negotiating:The ability to construct and maintain a strong bargaining position to ensure positive response and agreement: striving for win-win situations.
Adaptability:Must possess the 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.
Relentlessfocus on Quality and Transparencyas an organizational value.
You're the right fit if:
MS or PhD in a relevant field including Electrical, Mechanical Engineering, or other related science.
A minimum of 12+ years of experience successfully developing complex medical device (hardware, software, consumables) products for acute care/hospital markets is necessary.
Additional technical knowledge and hands-on experience in ventilation will be added advantage.
Defines User Requirements, system requirements, FMEA, 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
Experience with Sustenance Engineering, Change review Board, Defect Management
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
Analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
Strong understanding of System Design process including Model-based Design approach and Test-Driven design methodologies
Review System Verification and Validation plan/protocols, Test Method Validation (TMV)
Conducting Technical Review & Decision Making
Understanding of global medical device regulatory environments and clearance processes.
Effective communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team.
Maintains strict confidentiality of sensitive information.
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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