Senior Mechanical Engineer; Medical Devices

Sr. Mechanical Engineer

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.

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 ISO
  14971 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 in a relevant industrial setting (regulated environment; Med Tech is a strong plus) with proven experience executing a full development cycle. Experience in developing multidisciplinary medical devices is a plus.
• 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 (ISO
  13485) 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…