R&D Project Leader

Freelance R&D Project Leader - Cardiovascular Medical Devices

Contract Duration: 6-12 months (with potential extension)
Working Arrangement: Hybrid (4 days on-site / 1 day remote per week)
Location: Barcelona, Spain
Commitment: Full-time, 40 hours per week
Industry Focus: Cardiovascular stents - specifically drug-eluting stents

Role Overview

We are seeking an experienced R&D Project Leader to direct the full-cycle development of a medical device delivery system, from conceptual design and prototyping through to device verification and regulatory submission. This freelance role demands advanced technical leadership, project management capability, and knowledge of applicable quality standards.

Key Responsibilities

• Develop and implement technical project plans aligned with internal methodologies
• Collaborate with departmental leadership on budgeting and resource allocation
• Ensure technical feasibility and quality of engineering solutions
• Coordinate prototype manufacturing and production processes
• Lead initiatives to enhance product performance, quality, and cost-efficiency
• Define procurement specifications and oversee supplier qualification, ensuring continuity from development to factory transfer
• Prepare technical documentation for regulatory submissions, adhering to EU MDR and ISO standards

Candidate Profile

• Degree in Industrial Engineering, with emphasis in mechanical, electromechanical, materials science, or biomedical engineering
• Fluent in English and Spanish; Catalan is considered an asset
• Minimum five years of experience in a comparable R&D leadership role
• Proven experience with CAD tools including SolidWorks and Rhinoceros; proficiency with Ansys for simulation
• Prior involvement with implantable cardiovascular technologies such as stents or catheters
• Strong collaborative approach and cross-functional communication skills
• Excellent working knowledge of EU MDR and ISO 13485:2016 (Quality Management Systems), ISO 14971 (Risk Management), and ISO 10993 (Biocompatibility)