Senior Mechanical Engineer (with Medical Devices Experience)

Job description

Your Mission 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. Our mission is to decode and modulate neural networks to improve people's lives. As a Sr. Mechanical Engineer at INBRAIN you will lead the mechanical design and the development of an implantable component within the product while overseeing the different stages of the development. Currently, we are looking for 2 Senior Mechanical Engineers that would be focusing on development and design of active implantable medical devices (Class 3) or similar in complexity. You will be at the forefront of bringing advanced healthcare solutions to market, making a tangible difference in people´s lives worldwide. What You'll Do Main responsibilities: Lead the design, assembly, prototyping and of the mechanical components that are part of an implantable system in direct collaboration with the electronics, systems, quality and regulatory teams. Design for reliability, manufacture and test, including concept engineering, functional analysis, FEM analysis, and mechanical modelling. Deliver detailed documentation of the device design (BOM, drawings, Specifications, test plan,… ) compliant with ISO 13485 and ISO14971 design control requirements. Support and collaborate with external partners in the outsourced design, assembly and test of mechanical components that are part of an implantable electro-mechanical system. Define test plans and methods to verify safety and mechanical performance of the device, in compliance with applicable standards and in collaboration with other teams. Design and build and perform, experimental and product system setups necessary to perform bench tests, characterization testing, integration , system testing. Create test plans to verify our mechanical designs from the product requirements. Initiate and contribute to design, technical and milestone reviews. Understand DFR/DFM/DFT (Design for Reliability, Design for Manufacturing and Design for Test), including concept engineering, modelling, analysis, sensitivity, and stress analysis. Work intensively with Quality, Regulatory, Clinical and Project Management on the formal product development procedure, perform or collaborate in design and stage reviews. Mandatory Qualifications and Soft skills: BSc or MSc in Mechanical Engineering with at least 5 years of work experience within MedTech industry with proven experience executing a full development cycle. Experience in developing multidisciplinary medical devices. Minimum of 2 years of leading a technical mechanical engineering aspect of a project. Strong practical engineering background in mechanical engineering for commercial production. Familiar with electrical engineering, DFM, DFR and design methodologies and tools (e.g., Solidworks, PDM, etc.) Familiar with manufacturing processes such as design for assembly, design for test, pFMEA, etc. Ability to manage projects mandated to external sub-contractors and manufacturing. Fluency in English required (English is company language) . Fast learner, self-motivated and pro-active individual able to work in the fast-moving environment of a dynamic start-up company. A system-thinking attitude identify areas of potential improvement and develop plans to address these; Team oriented, a sparring partner to colleagues in other disciplines. Nice to have: Preferred to have solid experience in neuroscience with a strong interest in gaining a further understanding of this field. Strong hands-on skills, experience with machine shop tools. Extensive experience with active implantable medical device development Preferred to have experience in applying quality control for medical devices (ISO13485) or in a similar working environment in a tightly regulated industry (e.g., medical devices). Preferred to have a solid understanding of Medical Risk Analysis. Preferred to have detailed understanding of active implantable medical device development and application of its relevant standards Why us? 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. WHAT CAN WE OFFER TO YOU? 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. 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. 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. Competitive salary (according to your experience/skills) Internal flexible compensation scheme Private Health Insurance Training bonus for professional development and access to Udemy platform 23 vacation days per year Christmas week off Hybrid working modality Applications must be submitted in English 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! #diverseandinclusive 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.