Senior Mechanical Engineer

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Our client is an innovative deep-tech startup developing next-generation biosensor systems for in-vitro diagnostics. Combining photonics, microfluidics, and electronics, they are transforming complex lab processes into compact, high-performance diagnostic devices. Their mission is to accelerate access to accurate, fast, and energy-efficient diagnostics through advanced engineering and scalable product development.


Mission

Lead the productization and manufacturing scale-up of biosensor systems, ensuring a smooth transition from R&D to commercial production. The Senior Mechanical Engineer will own the full mechanical design process—from early prototyping to regulatory-compliant, cost-effective mass production—bridging innovation and manufacturability in a multidisciplinary environment.


Responsibilities


Productization & Manufacturing Scale-up

  • Own the mechanical design process from prototyping to production.
  • Optimize mechanical housings and microfluidic components for CNC machining, injection molding, and other scalable methods.
  • Develop and implement scalable manufacturing strategies with contract manufacturers.
  • Drive cost-reduction initiatives without compromising performance or quality.


Design, Validation & Compliance

  • Create and refine mechanical assemblies using SolidWorks, CATIA, or Fusion 360.
  • Apply tolerance analysis, GD&T, and DFM/DFA principles to ensure robust manufacturability.
  • Perform FEA/CFD simulations to validate performance (fluidics, thermal, structural).
  • Lead risk assessments (FMEA) and failure analysis for system reliability.


Cross-functional Collaboration

  • Work closely with photonics, microfluidics, and electronics teams to ensure seamless integration and transfer to production.
  • Support regulatory documentation (ISO 13485, MDR/FDA) for compliance and medical device approval.
  • Define quality control protocols and assembly procedures to ensure production readiness.


Requirements

  • Bachelor’s or Master’s degree in Mechanical, Industrial Engineering, or related fields.
  • 4+ years of experience in mechanical design & product development, ideally in medical devices, diagnostics, or precision engineering.
  • Proven track record transitioning lab prototypes to commercial products.
  • Strong knowledge of manufacturing processes: CNC machining, injection molding, sheet metal, etc.
  • Advanced proficiency in CAD tools: SolidWorks, CATIA, or Fusion 360.
  • Solid understanding of fluid handling, sealing techniques, and microfluidic integration.
  • Experience in tolerancing (GD&T) and design-for-manufacturability (DFM).
  • Familiarity with ISO 13485, FDA, MDR regulations and validation processes.
  • Fluent in English (spoken and written), with ability to produce technical documentation and collaborate across disciplines.

  • Ubicacion: Malaga, Spain
  • Tipo de trabajo: On Site
  • Sector: Fabricación de equipos médicos
  • Área: Ingeniería
  • F. Publicación: 19/04/2025
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