Requirements: English
Company: Bioherent
Region: Mlaga , Andalusia
Bioherent is pioneering state-of-the-art photonic biosensors to transform clinical diagnostics. As a deep-tech spin-off from the University of Mlaga, our cutting-edge biosensor technology is built on decades of research in photonics, chemistry, and clinical sciences. We are now scaling our technology to bring high-impact diagnostic solutions to market. Join us now to take on a high-impact leadership role in shaping next-generation medical diagnosticswhile living in one of Europes most sought-after cities! Why join us? Lead the transition from prototype to production of a novel biosensor system. Be a key player in a rapidly growing deep-tech company with a multidisciplinary team. Work on disruptive biosensing technology with real-world healthcare impact. Build a project from the ground up with a truly relevant socioeconomic impact. Collaboration with top experts in photonics, chemistry and medicine. Key responsabilities As a Senior Mechanical Engineer , you will lead the productization and manufacturing of Bioherents biosensor systems, ensuring a scalable, cost-efficient, and regulatory-compliant transition from R&D to commercial production. You will drive mechanical innovation, manufacturability, and quality assurance, collaborating with cross-functional teams in photonics, microfluidics, and electronics. Your responsibilities will include: Productization & manufacturing scale-up: Own the mechanical design processfrom prototyping to full-scale production. Optimize mechanical housing and microfluidic components for manufacturability. Develop scalable manufacturing strategies, working with contract manufacturers. Drive cost reduction efforts to ensure efficient mass production. Design, validation & compliance: Design mechanical assemblies using CAD software (SolidWorks, CATIA, Fusion 360). Conduct tolerance analysis, GD&T, and DFM/DFA for robust manufacturing. Validate designs with FEA/CFD simulations (fluidics and thermal management). Perform risk assessments (FMEA) and failure analysis to ensure reliability. Cross-functional collaboration Bridge the gap between mechanical, photonic, and microfluidic design. Support regulatory documentation (ISO 13485, MDR/FDA compliance). Define quality control guidelines and assembly procedures to streamline production. Who you are You successfully transitioned prototypes into commercial products. Experience with contract manufacturing, design transfer, and production methods. You enjoy building, testing, and refining prototypes. You are familiar with ISO 13485, FDA/MDR regulations. You work well in fast-paced, multidisciplinary environments. Required skills Bachelors or masters in mechanical engineering, industrial engineering, or a related. 4+ years of experience in mechanical design & product development. Advanced CAD proficiency (SolidWorks, CATIA, Fusion 360). Deep knowledge of manufacturing processes (CNC, injection molding, etc.). Strong understanding of microfluidics, and sealing techniques for biosensors. Strong understanding of mechanical tolerancing, GDCT, and DFM principles. Experience working with contract manufacturers and scaling production. Fluent in English (spoken and written). Preferred skills Experience in IVD or diagnostic device development. Knowledge of biocompatible materials and sterilization techniques. Familiarity with fluidic simulation tools (COMSOL, ANSYS Fluent). Hands-on experience with sensor integration in biosensing systems.