R&D PROJECT MANAGER

il y a 2 jours

Palaiseau, Île-de-France Kathie Medical Temps plein

KATHIE MEDICAL SAS
is a French MedTech startup, incubated at École Polytechnique, developing a new generation of smart medical devices for critical drainage.

Our ambition is to transform life-saving procedures that have seen little innovation, by combining advanced engineering, deep clinical insight and breakthrough sensing technologies.

We are building robust, impactful solutions with a clear path toward international market adoption.

To support this momentum, we are expanding our team and are looking for a
R&D Project Manager
to help drive and structure the development of our products.

The R&D Project Manager is responsible for driving and coordinating multidisciplinary development projects, from early concept and design phases through market launch in Europe, United States and Worldwide.

Key Responsibilities

· Identify, analyze, and formalize user needs in close collaboration with Surgeons and Interventional Radiologists, translating clinical practices and constraints into clear technical and functional requirements

· Define and maintain product specifications in compliance with applicable medical device regulations and standards.

· Assess project challenges, risks, and required resources, including budget, timelines, and human resources

· Plan, coordinate, and lead multidisciplinary partners and stakeholders, including R&D, clinical, regulatory, quality, industrial, and external partners or suppliers?

· Proactively identify project deviations and risks (technical, regulatory, planning, or cost-related) and implement corrective and preventive actions to ensure project objectives are met.

· Manage project execution in accordance with the company's Design Control and Development Process, ensuring full traceability and documentation throughout the product lifecycle.

· Monitor and report project progress through structured reporting to top management, providing clear visibility on milestones, risks, and key decisions.

· Prepare and lead design reviews and project reviews, ensuring alignment with regulatory expectations (EU MDR, FDA) and internal quality processes.

· Support product follow-up during commercialization, including post-market activities, product performance monitoring, and continuous improvement, to ensure product reliability, safety, and competitiveness.

· Contribute to the continuous improvement of project management and development processes within a fast-growing startup environment.

Profile

· PhD or Master's degree (MSc / Engineering degree or equivalent) in a relevant scientific or engineering field.

· Minimum 3 years of successful experience as a R&D Project Manager or Technical Product Manager in the medical device industry.

· Strong knowledge of medical device development, ideally including Class IIb/Class III devices and Design Control processes.

· Fluent English required (written and spoken), with the ability to work in an international regulatory and clinical context.

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