SYSTEMS ARCHITECT (WITH MEDICAL DEVICES EXPERIENCE) WITH ENGLISH
Descripción de la oferta de empleo
The company believes in shared success and diverse ways of thinking, here you’ll learn, grow, and advance in an innovative culture.
The System Architect is responsible for designing and engineering a complex Implantable Neuro-stimulation System 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).
The position is part of the System Engineering team and reports to the Systems Team Lead.
Main Responsibilities Translate customer requirements into system requirements and interface definitions Establish architecture design and decompose the system into lower-level building blocks Assess the feasibility of technology and contribute to technical concepts Perform functional analysis and create system designs to meet requirements Contribute to high-level technical planning, supplier work package definition Lead system integration and system testing of prototypes Initiate preliminary hazard analysis and establish the risk management plan Lead FMEA (Failure Mode and Effects Analysis) on the system Create a master verification plan for product and manufacturing requirements Ensure traceability between requirements, test cases, verification, and reports Organize technical reviews, contribute to design reviews and milestone reviews Generate intellectual property Work with Quality, Regulatory, Clinical, and Project Management on formal product development processes Own the product development lifecycle, including maintenance and service Guides the development team in manufacturing process qualifications and validations Core Skills/experience Bachelor's or Master's degree in a relevant engineering discipline Relevant industry experience of at least 5 years in medical devices or another highly regulated environment Strong engineering background (e.
., mechanics, electronics, software) with a generalist view of system engineering Experience in delivering complete systems to market (preferably active implantable medical devices) Preferably experience with the development of active implantable medical devices Experience with DRM/DFT (Design for Reliability, Manufacturing, and Test) Familiarity with agile processes, continuous development, continuous integration, and test automation A high-energy, self-motivated, and pro-active individual able to work in a diverse team in a startup company.
Good analytical skills Reliable, pragmatic, and result-oriented Good communication and presentation skills Fluency in English Spanish is a nice to have
Detalles de la oferta
- Sin especificar
- Sin especificar
- 27/09/2024
- 26/12/2024
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