Structural R&D Project Leader

• Indefinite and stable contract in a project with a high global impact and in the midst of an international expansion process.
• Professional and personal development in a young and dynamic environment.
• Competitive salary based on experience and an attractive benefits package.
• Flexible schedule for personal/family work-life balance.
• Flexible compensation (restaurant vouchers, transport, and childcare).
• Access to the iWellness program: gym and physiotherapist in our facilities.
• Corporate events and gifts.
• Subsidized company canteen.

LVD Biotech - iVascular Group is an international medical technology group specializing in the development, manufacturing, marketing, and distribution of innovative medical devices for the treatment of vascular system pathologies worldwide. Our vertical integration model allows us to integrate the entire product lifecycle.

The group is formed by two highly specialized and complementary companies:

• LVD Biotech, our innovation center, leads and drives the research and development of new technologies, managing the complete product development cycle from the initial idea conception to the preparation of the registration dossier, including the generation and protection of knowledge through intellectual property.
• iVascular converts that innovation into medical solutions that reach healthcare professionals and patients through the manufacturing, logistics, marketing, and international commercialization of a portfolio of medical devices for the Coronary, Peripheral, and Neurovascular areas.

With a team of more than 600 professionals and a commercial presence in more than 86 countries, both companies work in an integrated manner in a continuous collaboration environment that combines science, innovation, industrial excellence, and the highest quality standards. Together, we drive the development of medical solutions based on cutting-edge technologies with a common goal: to improve the quality of life of patients worldwide.

Lead the development of medical devices from the design phase through to their transfer to production, ensuring compliance with the technical, quality, cost, and deadline objectives defined by the company, in accordance with applicable regulations and the Quality Policy.

• Lead the end-to-end development of medical devices from concept, 2D/3D design, and prototyping to verification, validation, and transfer to production.
• Guarantee the technical feasibility of design solutions.

• Define design input and output requirements (product specifications).
• Plan, draft, coordinate, and monitor project work plans and derived reports.
• Develop and control the technical, cost, and deadline objectives associated with the project.
• Collaborate with the various departments involved to ensure and achieve the fulfillment of project objectives.

• Define, together with the department manager, the technical, human, and economic resources necessary for the projects.
• Participate in the preparation and monitoring of the project budget.

• Coordinate and supervise the manufacturing of prototypes and pilot batches necessary for the various development phases.
• Define the technical requirements for product industrialization (equipment, tooling, and processes).
• Draft User Requirement Specifications (URS) for the machinery and equipment necessary for product manufacturing.
• Define and review the procedures, production technical documentation, and process controls necessary for product manufacturing.
• Review the characterization of manufactured units and the associated technical documentation.
• Coordinate and carry out the commissioning of the production process and the transfer of the product to manufacturing.
• Define purchasing specifications and collaborate in the initial approval of suppliers, laying the groundwork for subsequent procurement purchases.

• Analyze technical incidents and lead the investigation and resolution of design failures.
• Investigate and promote opportunities for product and process improvements oriented toward quality, cost, and efficiency.
• Contribute to the continuous improvement and optimization of the new product's manufacturing process.

• Plan and lead product verification and validation activities, including the coordination of bench testing, analysis of results, drafting of reports, and associated technical documentation.
• Prepare and manage the product Technical Dossier to obtain regulatory approvals (MDR, FDA, PMDA), ensuring its traceability.
• Lead the investigation, verification, validation, analysis, and resolution of potential technical failures and incidents arising during the design development of the new product (including risk analysis, FMEA, and associated documentation).
• Prepare and review process and equipment validation protocols and reports (OQ/PQ).
• Guarantee compliance with applicable regulatory requirements and provide technical support

Minimum 6 years in an R&D department (preferably in the Medical Device sector) in product development across all its phases: design, validation, manufacturing processes, and quality.

• High capacity for multidisciplinary work, analytical capacity, creativity, integrity, spirit of cooperation, and communication skills.
• Profile especially oriented toward critical evaluation and goal achievement. Innovative mindset, high self-esteem, and high expectations for professional development.
• Necessary software: CAD (such as AutoCAD or similar), Solidworks (or similar). Experience in Matlab or Python and familiarity with AI is valued.