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.

• University studies in Scientific-Technical fields in Health Sciences or Engineering (Industrial Engineering, Mechanical, Biomedical,...)

Minimum 3 years in an R&D department (preferably in the Medical Device sector) in product development across all its phases: design, validation, manufacturing processes, quality.

Skills and attitudes:

• High capacity for multidisciplinary work, analytical capacity, creativity, integrity, spirit of cooperation, and communication skills.

• Profile especially oriented toward critical evaluation aimed at achieving objectives. Innovative mindset, high self-esteem, and high expectations for professional development.

• Necessary software: CAD (type AUTOCAD or similar), Solidworks (or similar). Experience in Matlab or Python is valued, as is familiarity with AI.

• A related Master's or PhD in development and design is valued.

Experience:

LVDBiotech & iVascular are a group of Medical Device companies located in Sant Vicenç dels Horts.

We specialize in the development, manufacture, and commercialization of advanced medical devices for the treatment of cardio, neuro, and endovascular diseases. Our focus is on offering minimally invasive solutions that truly improve patients' quality of life and becoming a benchmark in the vascular field by enhancing the value of technology and innovation.

To achieve this, we internally control the entire process: from research and development to production, sterilization, and distribution. We call this Vertical Integration, and it allows us to guarantee maximum quality, continuous innovation, and great agility to adapt to market needs.

We are a national company in a phase of growth and international expansion, with subsidiaries already established in Europe, America, and Asia.

Our purpose is very clear: to develop technologies that save and improve lives.

We are currently looking for an R&D Project Leader, who will be part of the R&D Department.

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 through to verification, validation, and transfer to production.

• Guarantee the technical feasibility of design solutions. Project Management:

• Define design input and output requirements (product specifications).

• Plan, draft, coordinate, and monitor project work plans and derived reports.

• Elaborate 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. Resource and Budget Management

• 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. Industrialization and

• Coordinate and supervise the manufacture of prototypes and pilot batches necessary for the various development phases.

• Define the technical requirements for product industrialization (equipment, tooling, and processes). • Elaborate 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 supplier qualification, setting the foundations 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 manufacturing process.

• Plan and lead product verification and validation activities, including the coordination of bench testing, results analysis, report preparation, and associated technical documentation.

• Elaborate 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 possible technical failures and incidents arising during the development of the new product design (including risk analysis, FMEA, and associated documentation).

• Elaborate and review process and equipment validation protocols and reports (OQ/PQ).

• Guarantee compliance with applicable regulatory requirements and provide technical support during interactions with notified bodies and regulatory authorities.

Academic background: