Senior Mechanical Engineer (with Medical Devices Experience)

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{
  "id": "1426519",
  "name": "Senior Mechanical Engineer (with Medical Devices Experience)",
  "office": "Barcelona",
  "keywords": [],
  "schedule": "full-time",
  "createdAt": "2024-02-14T12:56:28+00:00",
  "seniority": "experienced",
  "department": "Development",
  "occupation": "mechanical_engineering",
  "subcompany": "Inbrain Neuroelectronics, S.L.",
  "employmentType": "permanent",
  "jobDescriptions": [
    {
      "name": "Your mission",
      "value": "We are scientists, doctors, techies and humanity lovers, with the mission of building neuroelectronic interfaces to cure brain disorders. INBRAIN harnesses the extraordinary material properties of Graphene, the world’s thinnest and nobel-prize winning material, to build safe, uninvasive and highly efficient neural solutions.<em> Our mission is to decode and modulate neural networks to improve people's lives.</em><br><br>As a <strong>Sr.</strong> <strong>Mechanical Engineer </strong>at INBRAIN you will be contributing to the Design, development, and test of mechanical systems. These mechanical systems are part of a complex CNS neuromodulation implant and its peripheral equipment. This active medical device will be released in EU, requiring CE mark according to the MDR, and in the USA, requiring FDA approval. As a Sr Mechanical Engineer you will investigate, create concepts, design, develop and test mechanical components, assemblies, and systems.<br><br><strong>Currently, we are looking for 2 Senior Mechanical Engineers </strong>that would be focusing on development and design of active implantable medical devices (Class 3) or similar in complexity.<br><br>You will be at the forefront of bringing advanced healthcare solutions to market, making a tangible difference in people´s lives worldwide."
    },
    {
      "name": "Your profile",
      "value": "<br><strong>Main responsibilities:</strong><br><br><ul><li><span><span>Lead the design, assembly, prototyping and of the mechanical components that are part of an  implantable </span><span>system </span><span>in direct collaboration with the electronics, systems, </span><span>quality </span><span>and regulatory teams.</span></span><span><span> </span></span></li><li><span><span>Design for reliability, manufacture and test, including concept engineering, functional analysis, FEM analysis, and mechanical modelling.</span></span><span><span> </span></span></li><li><span><span>Deliver detailed documentation of the device design (BOM, drawings, Specifications, test </span><span>plan,…</span><span>) compliant with ISO 13485 and ISO14971 design control requirements. </span></span><span><span> </span></span></li><li><span><span>Support and collaborate with external partners in the outsourced design, assembly and test of mechanical components that are part of an implantable VNS system</span></span><span><span> </span></span></li><li><span><span>Define test plans and methods to verify safety and mechanical performance of the device, in compliance with applicable </span><span>standards</span><span> and in collaboration with other teams.</span></span></li><li><span><span>Design and build and perform, experimental and product system setups necessary to perform bench tests, characterization testing, integration</span><span>, system</span><span> testing.</span></span><span><span> </span></span></li><li><span><span>Create test plans to verify our mechanical designs from the product requirements.  </span></span><span><span> </span></span></li><li><span><span>Initiate and contribute to design, technical and milestone reviews.</span></span><span><span> </span></span></li><li><span><span>Understand DFR/DFM/DFT (Design for Reliability, Design for Manufacturing and Design for Test), including concept engineering, modelling, analysis, sensitivity, and stress analysis. </span></span><span><span> </span></span></li><li><span><span>Work intensively with Quality, Regulatory, Clinical and Project Management on the formal product development procedure, perform or collaborate in design and stage reviews.</span></span><span><span> </span></span></li></ul><br><strong>Mandatory Qualifications and Soft skills:</strong><br><br><ul><li>BS or MS in Mechanical Engineering with <strong>at least 5 years of work experience in Med Tech</strong> with a proven experience executing a full development cycle.</li><li><strong>+5 Year experience in the areas required to perform this job</strong>: Mechanical CAD design, Selection of medical-grade materials and components, safety and performance testing, Requirements based Design.</li><li>Capable and experience to oversee subcontracted activities.</li><li><div>Strong <strong>hands-on skills</strong>, experience with workshop tools.</div></li><li><div>Experience in (MDR) Medical Device Regulation, ISO 13485 Quality environments, ISO 14971 Risk Analysis and IEC 60601.</div></li><li><span><span>Fun, loving, </span><span>people person</span><span>. </span></span><span><span> </span></span></li><li><span><span>Fast learner, self-motivated and pro-active individual able to work in the fast-moving environment of a dynamic start-up company.</span></span><span><span> </span></span></li><li><span><span>A system-thinking attitude </span><span>identify</span><span> areas of potential improvement and </span><span>develop</span><span> plans to address these; Team oriented, a sparring partner to colleagues in other disciplines.</span></span></li></ul><br><span><strong>Nice to have:</strong></span><br><ul><li><span><span>Preferred to have solid experience in neuroscience with a strong interest in gaining a further understanding of this field.</span></span><span><span> </span></span></li><li><span><span>Preferred to have experience in applying quality control for medical devices (ISO13485) or in a similar working environment in a tightly regulated industry (</span><span>e.g.</span><span> medical devices);</span></span><span><span> </span></span></li><li><span><span>Preferred to have </span><span>solid</span><span> understanding of Medical Risk Analysis.</span></span><span><span> </span></span></li></ul>"
    },
    {
      "name": "Why us?",
      "value": "<br>We are looking for someone who Is ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. At INBRAIN we believe in shared success and diverse ways of thinking, here you'll learn, grow, and advance in an innovative culture.<br><br><strong>WHAT CAN WE OFFER TO YOU?</strong><strong> </strong><br><ul><li>A collaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect. </li><li>Meaningful Work Impact: Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change. </li><li>Cutting-Edge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry. </li><li>Competitive salary (according to your experience/skills) </li><li style=\"border:0px solid;margin:0px;font-family:inherit;list-style-type:disc;\">Internal flexible compensation scheme</li><li>Private Health Insurance </li><li>Training bonus for professional development and access to Udemy platform</li><li>23 vacation days per year</li><li>Christmas week off</li><li>Hybrid working modality</li></ul><strong><em>Applications must be submitted in English</em></strong><br><br>At INBRAIN, we're not just offering a job – we're inviting you to be part of a transformative journey, Are you ready to transform lives? Join us!<br><br><strong><em>#diverseandinclusive</em></strong><em><strong> </strong></em><br>We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation, identity and diverse abilities or any other status."
    }
  ],
  "occupationCategory": "engineering",
  "recruitingCategory": "Permanent Employee"
}