Senior Mechanical Engineer (with Medical Devices Experience)

Inbrain Neuroelectronics; Bellprat; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Private Health Insurance

Training bonus

Udemy access

23 vacation days

Christmas week off

Hybrid working

Job summary

INBRAIN Neuroelectronics is seeking 2 Senior Mechanical Engineers to lead the design and development of active implantable medical devices (Class 3). You will oversee mechanical components across the product lifecycle, ensuring reliability, manufacturability, and regulatory compliance.

You will collaborate with electronics, systems, quality and regulatory teams, manage external partners, and drive design reviews to meet project milestones in a dynamic startup environment.

Qualifications

• BSc or MSc in Mechanical Engineering with at least 5 years in MedTech and full development cycle experience.
• Experience in developing multidisciplinary medical devices.
• Minimum of 2 years leading a mechanical engineering aspect of a project.
• Strong practical engineering background for commercial production.
• Familiar with electrical engineering, DFM, DFR and design methodologies and tools (SolidWorks, PDM).
• Familiar with manufacturing processes such as design for assembly, test, PFMEA, etc.
• Ability to manage projects with external subcontractors and manufacturing.
• Fluency in English (company language).
• Fast learner, self-motivated, proactive in a fast-moving startup.
• System-thinking attitude and teamwork.

Responsibilities

• Lead design, assembly, prototyping of mechanical components of implantable system.
• Perform reliability, manufacture and test design, including concept engineering and analysis.
• Deliver device design documentation (BOM, drawings, specs, test plans) per ISO13485 and ISO14971.
• Support external partners in outsourced design, assembly and test of mechanical components.
• Define test plans to verify safety and mechanical performance per standards.
• Build and run bench tests, characterization, integration, system testing.
• Create test plans to verify designs from requirements.
• Participate in design, technical and milestone reviews.
• Understand DFR/DFM/DFT and perform modelling and stress analysis.
• Collaborate with Quality, Regulatory, Clinical and PM on development procedures.

Skills

Design for reliability

DFR/DFM/DFT

FEM analysis

Mechanical modelling

BOM, drawings, specs

ISO13485

Regulatory collaboration

English fluency

Project management

Quality collaboration

Education

BSc in Mechanical Engineering

MSc in Mechanical Engineering

Tools

SolidWorks

PDM

Job description

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 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.

Your profile

Main responsibilities:

• Lead the design, assembly, prototyping and of the mechanical components that are part of an implantablesystemin direct collaboration with the electronics, systems,qualityand 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, testplan,…) compliant with ISO 13485 and ISO14971 design control requirements.
• Support and collaborate with external partners in the outsourced design, assembly and test of mechanicalcomponents 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 applicablestandardsand in collaboration with other teams.
• Design and build and perform, experimental and product system setups necessary to perform bench tests, characterization testing, integration, systemtesting.
• 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 atleast5yearsofworkexperiencewithinMedTechindustry withprovenexperienceexecutingafulldevelopmentcycle.
• Experience in developing multidisciplinary medical devices.
• 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 (ISO13485) 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 detailed understanding of active implantable medical device development and application of its relevant standards

Why us?

We are looking for someone who Is ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. At INBRAIN we believe in shared success and diverse ways of thinking, here you'll learn, grow, and advance in an innovative culture.

WHAT CAN WE OFFER TO YOU?

• Acollaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect.
• Meaningful Work Impact:Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change.
• Cutting-Edge Technology Exposure:Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry.
• Competitive salary (according to your experience/skills)
• Internal flexible compensation scheme
• Private Health Insurance
• Training bonus for professional development and access to Udemy platform
• 23 vacation days per year
• Christmas week off
• Hybrid working modality

#diverseandinclusive

We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation, identity and diverse abilities or any other status.