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.