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Research and Development Lead
Job description
Noxtec Development S.L. is a small company dedicated to produce Medical
Devices. It is part of the Nippon Gases Group, a well know and recognised
international company. We design and produce high-technology medical devices
destinated to the international market.
We are looking for a Research and Development Lead,
who will manage product improvements and lead the new development project. The
R&D Development Lead will be responsible for the organization and execution
of the company development portfolio in the way that is stablished according to
the company Quality Management System.
The R&D Lead will be responsible for the
design, development and validation of new devices and the continuous
improvement of NOXtec's existing product portfolio.
Key Responsibilities:
Design and Prototyping:
* Participate in the conception and design of new products and subsystems (electronic, mechanical, software/firmware) from the conceptual phase to production.
* Develop and implement functional prototypes and proof-of-concept models.
Testing and Validation:
* Design, plan, and execute rigorous performance, safety, and reliability tests of devices.
* Analyse data, generate detailed technical reports, and propose solutions to problems encountered.
* Ensure verification and validation (V&V) of the design according to functional and regulatory requirements.
Documentation and Regulation:
* Prepare and maintain essential technical documentation for the Design History File (DHF), complying with medical device regulations (e.G., ISO 13485, MDR/FDA).
* Collaborate with the Regulatory Affairs team to ensure regulatory compliance.
Production Support:
*