Mechanical engineer

Freelance Mechanical Engineer - Class III Medical Devices Location: Brussels, Belgium Contract Type: Freelance Duration: 12-month contract Work Arrangement: Hybrid (3 days on-site per week) Start Date: Immediate Sponsorship: Not available - EU applicants only Company Overview A prominent European medical device manufacturer specialising in life-sustaining Class III technologies with a strong commitment to safety, innovation, and regulatory excellence. Operating from Brussels, the organisation develops advanced cardiovascular, neurovascular, and implantable therapeutic systems with global reach. Position Summary The company is seeking an experienced Mechanical Engineer with a robust background in Class III device development.

This freelance role will involve advanced mechanical design work for implantable or high-risk systems, contributing to critical design stages under rigorous regulatory constraints.

Key ResponsibilitiesLead design and development of mechanical components for Class III implantable medical devicesTranslate complex product requirements into engineered solutions aligned with MDR and ISO 13485 standardsConduct tolerance analyses, FMEA, and design verification testing specific to Class III devicesProduce risk management documentation and design history files (DHF) suitable for regulatory submissionCollaborate cross-functionally with R&D, regulatory affairs, manufacturing, and quality assurance teamsEngage with suppliers on prototype development and precision manufacturing of biocompatible components Candidate RequirementsBachelor's or Master's degree in Mechanical or Biomedical EngineeringMinimum five years' experience in Class III medical device developmentAdvanced proficiency in CAD software (SolidWorks preferred), with demonstrable expertise in tight-tolerance, high-reliability designsDeep understanding of biocompatible materials including titanium alloys and medical-grade polymersFamiliarity with sterilisation processes and cleanroom production protocolsMeticulous approach to design documentation and regulatory complianceEU work authorisation required - applications from non-EU candidates will not be considered Desired Skills and ExperienceMedical deviceMechanical EngineeringMedical Equipment ManufacturingISO13485MDR