Reporting to the CTO, As part of the R&D team, you will be responsible to supervise the design and the design control of our product Sasha – a autonomous robotized system for Stroke Treatment.
You will work with the different functional teams (SW, HW, Catheter, …) ensuring that all components of the system function together harmoniously to meet specified requirements.
YOUR ROLE AT ARTEDRONE...
Your responsibilities will include the following missions:
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
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
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)
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
Verification and Validation:
Oversee the verification & validation activities
Documentation:
Ensure deign control all design processes keeping records in compliance with company policies and regulatory standards
Reporting:
Provide regular project status updates to senior management, highlighting key milestones, risks, and opportunities.
Lead and mentor a multidisciplinary team.
WE WOULD LOVE TO HEAR FROM YOU IF YOU HAVE ...
An engineering degree or Master's in biomedical engineering, electrical engineering, mechanical engineering, software engineering, or a related field. Ph.D. is a plus.
At least 10 years' experience in the development of medical devices with active participation in the complete design cycle of at least two complex medical products.
Expertise in system design, integration, and development processes for medical devices
Strong knowledge of hardware/software interfaces, embedded systems, and communication protocols
Experience with medical device standards and regulatory requirements (FDA, IEC, ISO)
Proficiency with system modeling tools, CAD software, and simulation tools
Agile program management is a plus
Soft skills:
Proactive and autonomous, with the ability to drive projects forward
Innovative mindset, capable of developing and implementing technical solutions
Rigorous and results-driven, ensuring precision in experimental work
Strong interest and experience in in vitro testing
Excellent communication and teamwork skills for multidisciplinary collaboration
Strong leadership and ability to manage teams effectively.
Adaptable with a problem-solving mindset in dynamic environments.
Execution-focused, maintaining high standards throughout project development
WHILE AT ARTEDRONE YOU WILL ENJOY...
Competitive salary, based on experience, with performance-based bonuses.
Comprehensive benefits, including health insurance, transport reimbursement, meal vouchers, and seniority leave in accordance with the metallurgy collective agreement.
A dynamic and collaborative work environment in Paris (13th arrondissement).
Occasional remote work
Artedrone is an equal opportunity employer and values a diverse and inclusive workplace. All persons will receive consideration for employment without regard to gender, national origin, age, religion, sexual orientation, disability etc.
To apply: send your CV and cover letter to hr@artedrone.com while mentioning the reference of the offer (REF: 202503-03)