Research And Development Manager
hace 2 días
Barcelona
R&D Manager - Medical Devices (High‑Risk Class III) - Freelance (6 Months) Location: Barcelona, Spain (On‑Site) Contract: 6‑month freelance contract with the possibility of a permanent offer Industry: High‑Risk Medical Devices About the Role We are seeking an experienced R&D Manager to lead the development of high‑risk Class III medical devices-specifically balloon catheters, vascular stents, or comparable interventional products. You will manage a multidisciplinary team of engineers and drive projects from early‑stage feasibility through design, verification, qualification, and transfer to manufacturing. Spanish language skills are not required. Full‑time on‑site presence in Barcelona is essential. Key Responsibilities R&D Leadership & Team Management • Lead and mentor a team of R&D engineers, providing technical direction, workload prioritization, and performance development., • Oversee daily engineering activities including design iterations, prototyping, test planning, and documentation., • Establish and enforce robust engineering processes aligned with global regulatory expectations. Design & Development of High‑Risk Devices • Own the full design life cycle, from concept development and feasibility testing through to final design freeze., • Drive detailed engineering work for balloon catheters, stents, or similar interventional devices, including:, • Balloon forming and bonding processes, • Stent design, coatings, and mechanical performance, • Catheter shaft architecture and material selection, • Tolerance analysis, DFM/A, material characterisation, • Lead Verification & Validation (V&V) strategy, including test method development, equipment qualification, and protocol/report generation. Qualification & Industrialisation • Manage design qualification, including performance testing, biocompatibility considerations, sterilisation validation input, and packaging qualification., • Oversee transfer of designs into manufacturing / scale‑up, collaborating with process engineering and suppliers. Project & Stakeholder Management • Act as project owner for multiple R&D programmes, managing timelines, budgets, risk registers, and resource allocation., • Coordinate with Quality, Regulatory, Clinical, and Operations teams to ensure coherent project execution., • Present project updates to leadership, aligning on strategy, risks, and technical decisions. Regulatory & Compliance (FDA and MDR) • Ensure all R&D activities adhere to Design Control requirements under 21 CFR 820 and EU MDR., • Lead or contribute to core regulatorydeliverables, including:, • Design History File (DHF), • Risk Management File (ISO 14971), • Design Inputs/Outputs, • Verification/Validation documentation, • Support regulatory submissions through technical report preparation and cross‑functional input. Required Experience • Minimum 3 years' experience in R&D management within the medical device sector., • Proven hands‑on experience with high‑risk Class III devices, preferably balloon catheters or stents., • Demonstrated ability to lead engineering teams and manage complex technical projects., • Strong understanding of Design Controls, Risk Management, V&V, and qualification activities., • Proficiency with FDA 21 CFR 820, EU MDR, ISO 13485, and ISO 14971., • Excellent organisational and communication skills., • Ability to work full‑time on site in Barcelona.
