Company Description

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

We specialize in the development, manufacturing, and commercialization of advanced medical devices for the treatment of cardiovascular, neurovascular, and endovascular diseases. Our focus is on providing minimally invasive solutions that truly improve patients’ quality of life and to become a reference in the vascular field by enhancing the value of technology and innovation.

To achieve this, we manage the entire process internally—from research and development to production, sterilization, and distribution. We call this Vertical Integration, and it allows us to ensure the highest quality, continuous innovation, and strong agility to adapt to market needs.

We are a national company in a growth phase and undergoing international expansion, with subsidiaries already established in Europe, the Americas, and Asia.

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

Position

We are looking for an R&D; Project Leader to join the R&D; Department.

YOUR MISSION:

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

DUTIES AND RESPONSIBILITIES:

Product Development Leadership

- Lead the end-to-end development of medical devices from concept, 2D/3D design and prototyping through to verification, validation and transfer to production.
- Ensure 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 the resulting reports.
- Define and control the technical, cost and timeline objectives associated with the project.
- Collaborate with the different departments involved to ensure and achieve compliance with the project objectives.

Resource and Budget Management

- Define, together with the department manager, the technical,



human and financial resources required for the projects.
- Participate in the preparation and monitoring of the project budget.

Industrialization and Transfer to Production:

- Coordinate and supervise the manufacture of prototypes and pilot batches required for the different development phases.
- Define the technical requirements for product industrialization (equipment, tooling and processes).
- Prepare the user requirement specifications (URS) for the machinery and equipment required for product manufacturing.
- Define and review the procedures, technical production documentation and process controls required for product manufacturing.
- Review the characterization of manufactured units and the associated technical documentation.
- Coordinate and carry out the start-up of the production process and the transfer of the product to manufacturing.
- Define purchasing specifications and collaborate in the initial approval of suppliers, establishing the basis for subsequent procurement purchases.

Continuous Improvement and Technical Support:

- Analyze technical incidents and lead the investigation and resolution of design failures.
- Investigate and promote opportunities for product and process improvements focused on quality, cost and efficiency.
- Contribute to the continuous improvement and optimization of the manufacturing process for the new product.

Quality, Validation and Regulatory Documentation:

- Plan and lead product verification and validation activities, including the coordination of bench testing, analysis of results, preparation 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 possible failures and technical incidents arising during the development of the new product design, including risk analysis, FMEA and associated documentation.
- Prepare and review process and equipment validation protocols and reports (OQ/PQ).
- Ensure compliance with applicable regulatory requirements and provide technical support during interactions with notified bodies and regulatory authorities.

Requirements

DESIRED PROFILE:

Academic background

- University studies in Scientific-Technical fields related to Health Sciences or Engineering (Industrial, Mechanical, Biomedical Engineering, …)
- Master’s degree or PhD related to development and design will be valued.

Experience

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 and quality.

Skills and attitudes

- Strong ability to work in multidisciplinary environments, analytical skills, creativity, integrity, spirit of cooperation and communication skills.
- Profile especially oriented towards critical evaluation and achievement of objectives. Innovative mindset, high self-esteem and high expectations for professional development.
- Required software: CAD, such as AutoCAD or similar, SolidWorks or similar. Experience with Matlab or Python and familiarity with AI will be valued.

Other information

WHAT WE OFFER:

- Permanent and stable contract in a project with high general impact and expanding internationally.
- Professional and personal development in a vibrant, dynamic, and youthful environment.
- Competitive salary tailored to your experience, along with an attractive benefits package.
- Flexible working hours to support a healthy work-life balance.
- Flexible compensation (meal vouchers, transportation, and childcare assistance).
- Access to our iWellness program: gym and physiotherapist on site.
- Corporate events and gifts.
- Subsidized on-site company cafeteria.

Apply for this job

📌 R&D Project Leader (España)
🏢 iVascular
📍 España