Your mission
As a System Architect you will be responsible for the design and engineering of a complex Implantable, intelligent Neuro-modulation System for Deep Brain Modulation and its peripheral equipment. This active medical device will be released in both the EU requiring CE mark according to the MDR and the USA (FDA approval).
Your main responsibilities as Systems Architect at INBRAIN will be:
Your main responsibilities as Systems Architect at INBRAIN will be:
- Translates customer requirements into system requirement and interface definitions.
- Assess feasibility of technology and contribute to technical concepts.
- Establish architecture design and decompose the system into lower-level building blocks.
- Perform functional analysis, create system designs meeting requirements.
- Contribute to high-level technical planning, supplier work package definition.
- Assess applicability of standards and norms.
- Initiate preliminary hazard analysis and establish the risk management plan.
- Lead the FMEA on system level.
- Lead system integration and system testing of prototypes.
- Ensure traceability between requirements, test cases, verification, and reports.
- Create master verification plan for product and manufacturing requirements.
- Create, maintain, and monitor configuration management.
- Organize technical reviews, contribute to design reviews and milestone reviews.
- Generate intellectual property.
- Daily review, design, requirements, and integration activities
- Understand DRM/DFT (Design for Reliability, Design for Manufacturing and Design for Test), including concept engineering, modelling, analysis, sensitivity, and stress analysis.
- Familiar with agile processes, continuous development, continuous integration, and test automation.
- Work intensively with Quality, Regulatory, Clinical and Project Management on the formal product development processes, perform design and phase reviews.
- Owns the product development lifecycle, including maintenance, service, etc.
- Guides the development team in manufacturing process qualifications and validations.
- Follow change request processes.