Senior Mechanical Engineer (with Medical Devices Experience)
Permanent employee, Full-time · Barcelona
Your mission
As a Mechanical Engineer at INBRAIN, you will contribute to the design, development, and testing 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 the 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 responsibilities: Lead the design, assembly, prototyping, and testing of 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 modeling.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 testing 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, build, and perform experimental and product system setups necessary to perform bench tests, characterization testing, integration, and system testing.Identify subcontractors who can provide mechanical development and prototype build services to INBRAIN, and manage projects assigned to such third 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, modeling, analysis, sensitivity, and stress analysis.Work intensively with Quality, Regulatory, Clinical, and Project Management on the formal product development procedure, performing or collaborating in design and stage reviews.Follow change request processes.Initiate and contribute to design, technical, and milestone reviews.Your profile
BS or MS in Mechanical Engineering with at least 5 years of work experience in a relevant industrial setting (regulated environment, MedTech 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 technically oriented teams.
#J-18808-Ljbffr