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.
#J-18808-Ljbffr