Systems Architect for Medical Devices

hace 4 días

Barcelona, Barcelona, España Inbrain Neuroelectronics A tiempo completo

Job Summary

The Systems Architect will be 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).

Key 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
  • Guide the development team in manufacturing process qualifications and validations

Requirements:
  • 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.g., 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

About Us

We are a company that believes in shared success and diverse ways of thinking. We thrive on open communication, knowledge sharing, and mutual respect. Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. We offer a collaborative environment where innovative ideas flourish and teamwork drives us forward. We believe that a diverse and well-balanced workforce drives innovation. We foster the inclusion of all people regardless of culture, age, gender, sexual orientation, and identity, or any other status. We are looking for someone who is ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. We offer a competitive salary (according to your experience/skills), payflow & flexflow, private health insurance (optional), training bonus for professional development, 23 vacation days per year + 24th and 31st of December, and hybrid working modality.

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