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hace 1 mes
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.
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