Senior Mechanical Engineer

Steneg; Málaga; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An innovative deep-tech startup is seeking a Senior Mechanical Engineer to lead the productization and manufacturing scale-up of cutting-edge biosensor systems. This role involves overseeing the mechanical design process from early prototyping to commercial production, ensuring compliance with regulatory standards while optimizing for cost and performance. The ideal candidate will have a strong background in mechanical design, product development, and manufacturing processes, particularly in the medical device sector. Join a forward-thinking company that is transforming diagnostics with advanced engineering and scalable solutions, and make a significant impact in the field of healthcare technology.

Formación

• 4+ years of experience in mechanical design & product development.
• Strong knowledge of manufacturing processes and CAD tools.

Responsabilidades

• Own the mechanical design process from prototyping to production.
• Optimize mechanical housings for scalable manufacturing methods.
• Collaborate with cross-functional teams for seamless integration.

Conocimientos

Mechanical Design

Product Development

CNC Machining

Injection Molding

Fluid Handling

Tolerance Analysis (GD&T)

FMEA

Technical Documentation

Cross-functional Collaboration

Regulatory Compliance

Educación

Bachelor’s degree in Mechanical Engineering

Master’s degree in Mechanical 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

1. Own the mechanical design process from prototyping to production.
2. Optimize mechanical housings and microfluidic components for CNC machining, injection molding, and other scalable methods.
3. Develop and implement scalable manufacturing strategies with contract manufacturers.
4. Drive cost-reduction initiatives without compromising performance or quality.

Design, Validation & Compliance

1. Create and refine mechanical assemblies using SolidWorks, CATIA, or Fusion 360.
2. Apply tolerance analysis, GD&T, and DFM/DFA principles to ensure robust manufacturability.
3. Perform FEA/CFD simulations to validate performance (fluidics, thermal, structural).
4. Lead risk assessments (FMEA) and failure analysis for system reliability.

Cross-functional Collaboration

1. Work closely with photonics, microfluidics, and electronics teams to ensure seamless integration and transfer to production.
2. Support regulatory documentation (ISO 13485, MDR/FDA) for compliance and medical device approval.
3. Define quality control protocols and assembly procedures to ensure production readiness.

Requirements

1. Bachelor’s or Master’s degree in Mechanical, Industrial Engineering, or related fields.
2. 4+ years of experience in mechanical design & product development, ideally in medical devices, diagnostics, or precision engineering.
3. Proven track record transitioning lab prototypes to commercial products.
4. Strong knowledge of manufacturing processes: CNC machining, injection molding, sheet metal, etc.
5. Advanced proficiency in CAD tools: SolidWorks, CATIA, or Fusion 360.
6. Solid understanding of fluid handling, sealing techniques, and microfluidic integration.
7. Experience in tolerancing (GD&T) and design-for-manufacturability (DFM).
8. Familiarity with ISO 13485, FDA, MDR regulations and validation processes.
9. Fluent in English (spoken and written), with ability to produce technical documentation and collaborate across disciplines.