Your mission
As a 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 Mechanical Engineer you will investigate, create concepts, design, develop and test mechanical components, assemblies, and systems.
Main responsabilities:
Main responsabilities:
- Lead the design, assembly, prototyping and test mechanical components that are part of an implantable CNS neuromodulation system, in direct collaboration with the electronics, systems, quality and regulatory teams.
- Work with clinicians, users, and other team members to define and evolve requirements and guidelines for the design of mechanical components.
- 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 ISO14971design control requirements.
- Support and collaborate with external partners in the outsourced design, assembly and test of mechanical components that are part of an implantable CNS neuromodulation system
- Qualify, validate and create maintenance plans for lab tools and equipment.
- 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.
- Identify sub-contractors who can be used to provide mechanical development and prototype build services to INBRAIN, and manage projects assigned to such 3rd parties.
- Create test plans to verify our mechanical designs from the product requirements.
- Generate intellectual property.
- 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.
- Follow change request processes.
- Initiate and contribute to design, technical and milestone reviews.