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 Responsibilities

• Lead design and development of mechanical components for Class III implantable medical devices
• Translate complex product requirements into engineered solutions aligned with MDR and ISO 13485 standards
• Conduct tolerance analyses, FMEA, and design verification testing specific to Class III devices
• Produce risk management documentation and design history files (DHF) suitable for regulatory submission
• Collaborate cross-functionally with R&D, regulatory affairs, manufacturing, and quality assurance teams
• Engage with suppliers on prototype development and precision manufacturing of biocompatible components

Candidate Requirements

• Bachelor's or Master's degree in Mechanical or Biomedical Engineering
• Minimum five years' experience in Class III medical device development
• Advanced proficiency in CAD software (SolidWorks preferred), with demonstrable expertise in tight-tolerance, high-reliability designs
• Deep understanding of biocompatible materials including titanium alloys and medical-grade polymers
• Familiarity with sterilisation processes and cleanroom production protocols
• Meticulous approach to design documentation and regulatory compliance
• EU work authorisation required - applications from non-EU candidates will not be considered