Chargement en cours

R&D ENGINEER -MEDICAL DEVICE H/F

BESANÇON, 25
il y a 24 jours

The R&D Engineer will be responsible for a significant part of the design and development of the future DIXI products and will help bring them through to FDA-cleared and CE-approved manufacturing. The device is highly integrated and very demanding in terms of micromechanics and must satisfy new clinical requirements. In addition, the R&D Engineer will participate in the improvement of the existing range of electrodes, surgical tools and accessories. This position works independently and with the teams to design new, best-in-class miniaturized medical devices. In this role, the R&D Engineer will support project execution by coordinating external partners, managing technical interfaces, and contributing hands‑on expertise to internal design and development activities. The R&D Engineer will contribute to project portfolio and the strategic technology plans thanks to his technical expertise.

Work relationships

Reports to R&D Director; interacts with cross‑functional internal teams including R&D, Production, Methods, Regulatory Affairs (RA), Quality Assurance (QA) and Purchasing; interacts also with suppliers and outsourced national and international R&D services companies. This role requires the ability to communicate technical information effectively. On‑site work at Dixi medical in Chaudefontaine (up to 20% home office work possible).

Significant activities and responsibilities

  • Design and develop highly integrated micromechanical systems and subsystems, either internally by performing modeling, simulation, and calculations, or externally by collaborating and supervising outsourced R&D and engineering services company
  • Assemble or supervise assembly of prototypes for development, verification, and validation testing
  • Conduct testing and characterization of prototypes to define and refine the final product specifications
  • Optimize system design for safety, performance, and manufacturability
  • Define system requirements and develop associated testing plans
  • Draft technical specifications for components and create detailed engineering drawings
  • Lead risk analysis (Design FMEA and Process FMEA) for micromechanical systems
  • Support EU and FDA compliance by validating manufacturing processes in collaboration with the industrialization department and ensuring adherence to regulatory standards and Medical Device GMP
  • Collaborate with industrialization and test teams to define and implement production and testing processes and instructions
  • Collaborate with the purchasing department to manage material sourcing, parts procurement, and inventory management
  • Partner with cross‑functional internal or external teams to bring medical device to the market for clinical use or for clinical studies
  • Contribute to other tasks as needed to support company operations and project success

Skills required

  • Real talent in innovative mechanical and micro‑mechanical design, autonomous and proactive
  • Ability to collaborate and co‑develop new solutions with external companies
  • Proficiency in SolidWorks required
  • Good knowledge of various production techniques (machining, injection, assembly etc.)
  • Good knowledge of geometric dimensioning and tolerancing
  • Experience in writing requirements and technical specifications
  • Experience in working in an ISO 13485 environment is an asset
  • Knowledge in medical manufacturing validation, GMP is an asset
  • Experience with measuring systems and electronics testing system is an asset
  • Demonstrated ability to work within a fast‑paced start‑up environment in a small team setting

Specific knowledge / Experience

  • Minimum of Master in Mechanical Engineering. Biomechanical or micro‑engineering is an asset
  • 5‑10 years of experience in R&D. Medical Device is an asset
  • Personal drive to make things happen - very hands‑on
  • Passionate about enhancing performance and reliability of innovative micromechanical medical system - for caregivers’ and patients' happiness
  • Committed to finding the best design for manufacturing solutions while keeping COGS low
  • Committed to finding the best technical solutions to enable the best possible user experience
  • Highly satisfied to be accountable for delivering on‑time products that exceed expectations
  • Strong at making right technical decisions especially in short deadline planning
  • A pleasant setting (new, air‑conditioned premises, etc.)
  • A stable job within a young, dynamic team, in a human‑size company committed to environmental protection and personal safety.

Social perks such as a 13th‑month bonus, meal vouchers, and a profit‑sharing bonus.

Sustainable mobility package (carpooling, cycling, and walking), health insurance, and provident coverage.

Innovation is at the heart of our mission. With over 50 years of microtechnical expertise and close collaboration with clinicians, we develop high‑precision medical devices that meet the most demanding standards of functional neurosurgery, always keeping patients at the center of every decision and development stage.

Fully aware of our environmental impact, we act for a more sustainable future through responsible manufacturing practices, electrode recycling initiatives, and continuous efforts to reduce our global footprint—demonstrating our commitment to a more responsible industry.

Close collaboration withhealthcare professionals

We work side by side with neurosurgeons, neurologists, and researchers to co‑develop solutions that meet real clinical needs. Our field presence, SEEG training programs, and daily exchanges with practitioners strengthen this trusted relationship.

Global Commitment

We collaborate with and supply to epilepsy centers in over 40 countries, helping to launch new SEEG programs and sharing our expertise through webinars, courses, conferences, and scientific partnerships.

  1. Recognized expertise Over 50 years of experience in microtechnology and functional neurosurgery.
  2. A human‑scale company Where every team member counts and can truly make a difference.
  3. Strong core values Gender equality, environmental responsibility, and clinical commitment.
  4. An international outlook Presence in over 40 countries and a U.S. subsidiary.
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Entreprise
Dixi Medical Holding SA
Plateforme de publication
WHATJOBS
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