Senior Mechanical Engineer

Steneg; Madrid; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

Join a pioneering deep-tech startup revolutionizing in-vitro diagnostics through advanced biosensor systems. As a Senior Mechanical Engineer, you will lead the productization and manufacturing scale-up of innovative diagnostic devices, ensuring a seamless transition from research to commercial production. This role involves optimizing mechanical designs, collaborating with multidisciplinary teams, and ensuring compliance with industry standards. If you are passionate about transforming complex lab processes into high-performance solutions and thrive in a dynamic environment, this opportunity is perfect for you.

Formación

• 4+ years of experience in mechanical design & product development.
• Proven track record transitioning lab prototypes to commercial products.

Responsabilidades

• Own the mechanical design process from prototyping to production.
• Develop scalable manufacturing strategies with contract manufacturers.

Conocimientos

Mechanical Design

Product Development

Manufacturing Processes

Tolerance Analysis

Fluid Handling

Sealing Techniques

Cross-functional Collaboration

Educación

Bachelor’s degree in Mechanical Engineering

Master’s degree in Mechanical Engineering

Bachelor’s degree in Industrial Engineering

Master’s degree in Industrial Engineering

Herramientas

SolidWorks

CATIA

Fusion 360

Descripción del empleo

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.