Tech Lead GraphTalk AIA - Assurance Vie (F / H) - Paris

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Chief Product Officer • Créteil

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Description de poste

Vida is delighted to be in a retained partnership with Artedrone. A French-based start-up that is pioneering the development of an autonomous robot to treat ischaemic stroke. To support their growth plans, they are looking to bring on board an experienced Lead System Designer.

As part of the R&D team, the Lead System Designer will be responsible for supervising the design and the design control of the company's product Sasha – an autonomous robotised system for stroke treatment. The LSD will work with the different functional teams, ensuring that all components of the system function together harmoniously to meet specified requirements.

Key responsibilities :

1. System Design and Architecture: Lead the system design and architecture, ensuring they meet user needs and regulatory requirements. Define system requirements, perform risk assessments, and establish a clear design vision that aligns with project goals and timelines.
2. Technical Leadership: Lead and mentor a multidisciplinary team of engineers, providing technical guidance and direction throughout the design lifecycle. Coordinate with cross-functional teams to ensure the seamless integration of all subsystems.
3. Regulatory Compliance: Ensure that the system design complies with relevant medical device regulations. Oversee the preparation of documentation for regulatory submissions and product approvals. Develop and maintain Design History Files (DHF).
4. Risk Management: Lead risk analysis activities (e.g., FMEA, hazard analysis) to identify and mitigate potential risks associated with the device's operation, safety, and reliability. Establish and maintain risk management plans to guide design decisions and document mitigation strategies.
5. Verification and Validation: Oversee the verification & validation activities.
6. Documentation: Ensure design control of all design processes, keeping records in compliance with company policies and regulatory standards.

Education & Experience :

1. Engineering degree or Master's in biomedical engineering, electrical engineering, mechanical engineering, software engineering, or a related field.
2. Ph.D. is a plus.
3. At least 10 years of experience in medical device development.
4. Hands-on involvement in the complete design cycle of a minimum of two complex medical products.

Professional Skills :

1. Expertise in system design, integration, and development processes for medical devices.
2. Strong knowledge of hardware / software interfaces, embedded systems, and communication protocols.
3. Experience with medical device standards and regulatory requirements (FDA, IEC, ISO).
4. Proficiency with system modeling tools, CAD software, and simulation tools.
5. Agile program management is a plus.

Soft Skills :

1. Proactive and autonomous, with the ability to drive projects forward.
2. Innovative mindset, capable of developing and implementing technical solutions.
3. Rigorous and results-driven, ensuring precision in experimental work.
4. Strong interest and experience in in vitro testing.
5. Excellent communication and teamwork skills for multidisciplinary collaboration.
6. Strong leadership and ability to manage teams effectively.
7. Adaptable with a problem-solving mindset in dynamic environments.
8. Execution-focused, maintaining high standards throughout project development.