Company Description

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 diseases worldwide. Our vertically integrated business model enables us to manage the entire product lifecycle, from innovation and development to manufacturing and commercialization.

The Group comprises two highly specialized and complementary companies:

- LVD Biotech, our innovation center, leads and drives research and development of new technologies, managing the entire product development cycle from the initial concept through to the preparation of regulatory dossiers. This includes generating, developing and protecting knowledge through intellectual property.
- iVascular transforms this innovation into medical solutions that reach healthcare professionals and patients through the manufacturing, logistics, marketing and international commercialization of a portfolio of medical devices across the Coronary, Peripheral and Neurovascular fields.

With a team of more than 600 professionals and a commercial presence in over 86 countries, both companies work closely together in an environment of continuous collaboration, combining science, innovation, industrial excellence and the highest quality standards.

Together, we drive the development of cutting-edge medical solutions with a shared goal: improving patients’ quality of life worldwide.

Position

YOUR MISSION:

Lead the development of medical devices from the design phase through to transfer to production, ensuring that the technical, quality, cost and timeline objectives defined by the company are met, in compliance 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 inputs and outputs (product specifications).
- Plan, draft, coordinate and monitor project work plans and the resulting reports.
- Establish and monitor the technical,



cost and timeline objectives associated with the project.
- Collaborate with the departments involved to ensure and achieve the project objectives.

Resource and Budget Management

- Define, together with the Head of Department, the technical, human and financial resources required for the projects.
- Participate in preparing and monitoring the project budget.

Industrialisation 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 industrialisation (equipment, tooling and processes).
- Prepare user requirements specifications (URS) for the machinery and equipment required to manufacture the product.
- Define and review the procedures, technical production documentation and process controls required to manufacture the product.
- Review the characterisation of the 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 qualification of suppliers, establishing the basis for subsequent procurement.

Continuous Improvement and Technical Support

- Analyse technical issues 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 optimisation 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 potential failures and technical issues 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).
- Ensure compliance with applicable regulatory requirements and provide technical support during interactions with notified bodies and regulatory authorities.

Requirements

DESIRED PROFILE:

Academic qualifications:

- University degree in a scientific or technical discipline within Health Sciences or Engineering (Industrial, Mechanical, Biomedical Engineering, …)
- A master’s degree or PhD related to development and design is desirable.

Experience:

A minimum of 6 years in an R&D; department (preferably in the Medical Device sector), working on all phases of product development: design, validation, manufacturing processes and quality.

Skills and attitudes:

- Strong multidisciplinary teamwork skills, analytical skills, creativity, integrity, a cooperative spirit and communication skills.
- A profile particularly focused on critical evaluation and achieving objectives. An 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 are desirable.

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

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