Senior Mechanical Engineer (with Medical Devices Experience)

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 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.

Currently, we are looking for 3 Senior Mechanical Engineers:  2 engineers that would be focusing on development and design of active implantable medical devices or similar in complexity and 1 engineer who would be focusing on transfer to manufacturing and commercialization.

You will be at the forefront of bringing advanced healthcare solutions to market, making a tangible difference in people´s lives worldwide.

Your profile

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 VNS 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:

• BS or MS in Mechanical Engineering with extensive work experience in Med Tech with a proven experience executing a full development cycle. 
• Strong experience in the areas required to perform this job: Mechanical CAD design, Selection of medical-grade materials and components, safety and performance testing., Requirements based Design. 
• Experience in (MDR) Medical Device Regulation, ISO 13485 Quality environments, ISO 14971 Risk Analysis and IEC 60601.
• Fun, loving, people person.  
• 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; Te