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.
- 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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