Senior Mechanical Engineer for Medical Devices

hace 7 días

Barcelona, Barcelona, España Inbrain Neuroelectronics A tiempo completo

Job Title: Senior Mechanical Engineer for Medical Devices

About the Role:

We are seeking a highly skilled Senior Mechanical Engineer to join our team at Inbrain Neuroelectronics. As a Senior Mechanical Engineer, you will be responsible for the design, development, and testing of mechanical systems for medical devices.

Main Responsibilities:

  • Lead the design, assembly, prototyping, and testing of mechanical components for medical implants.
  • 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 for medical implants.
  • 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 Neuroelectronics, 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.

Requirements:

  • 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).
  • 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.

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