R&D Engineer
Freelance R&D Engineer - Vascular Stents | 12-Month Contract | Spain (Hybrid)
A pioneering medical device company specialising in vascular stent technologies is seeking a freelance R&D Engineer to support its product development team over a 12-month hybrid assignment based in Spain. This role is ideal for seasoned professionals who bring deep technical knowledge, strong regulatory acumen, and hands-on experience navigating the intricacies of Class III implantable devices.
About the Company:
Operating at the forefront of vascular innovation, the company focuses on delivering next-generation stent solutions that improve patient outcomes and meet the evolving demands of EU MDR compliance. With a dynamic and collaborative culture, they offer an opportunity to contribute meaningfully to high-impact projects in a flexible working environment.
Role Overview:
As an engineer, you will play a central role in driving R&D activities from early-stage concept refinement through to design verification and validation. You will work closely with cross-functional teams including manufacturing, regulatory affairs, and quality to ensure design integrity and compliance across all documentation and submission phases.
Key Responsibilities:
- Lead product development efforts for vascular stent technologies within a hybrid working model
- Generate and maintain robust design control documentation aligned with EU MDR and ISO 13485 standards
- Design and execute test protocols for design verification and validation
- Support technical file creation for regulatory submissions
- Collaborate with internal experts and external partners across Europe to troubleshoot design challenges and optimise clinical performance
Candidate Profile:
- Minimum 3 years of experience in R&D within the medical device sector, specifically focused on vascular implants or Class III devices
- Proven track record of working within MDR frameworks; familiarity with Notified Body engagement is a plus
- Strong command of engineering principles relevant to stent design (materials, fatigue testing, biocompatibility)
- Fluent in technical English; Spanish language skills are advantageous but not mandatory
- Must be based in Spain or open to relocating; hybrid structure includes regular on-site engagement
- Non-EU sponsorship will not be considered due to regulatory restrictions.