Lead System Designer/Engineer H/F

Marseille /
R & D – System /
CDI statut cadre
/ Hybrid
Who we are?
Volta Medical is a young innovative start-up in the south of France, aimed at creating and bringing to the market AI software products to help cardiologists during heart surgeries. We are a team of HEC and Ecole Polytechnique graduates, as well as world-known cardiologists from France and the US working in a great environment in order to make a difference in the health market. Our main product is a therapeutic solution using a data-driven approach for treating AF based on intracardiac signals’ analysis. This solution builds on artificial intelligence approaches to gain insight into innovative therapies for AF. In fact, this represents one of the first fully AI-guided successful surgical procedures, serving as a revolutionary step in the field of AI. We have started this adventure for 6 years ago and now we are 60 employees! We raised a €23 M Series A round in November 2020 led by Gilde Healthcare (Largest Healthcare VC in Europe).Volta Medical is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status or any other characteristic protected by law.

Mission

As a member of the Engineering team, you will be responsible for the design and development of
Volta’s product in its system aspects. Working closely with product managers, R&D experts, quality
and regulatory teams, you will bring your expertise to integrate the Software and Hardware
components, ensuring the delivery of a reliable, maintainable product in compliance with standards.

Reporting to the VP of Engineering, you will:

● Interact with Product Managers to turn user and product requirements into system designs and system requirements
● Work with cross-functional teams to develop requirements flow down, architecture/system design and analysis, risk analysis, integration and testing
● Coordinate the system integration and ensure the balance between functionality, quality, reliability, compliance and cost
● Lead the R&D activities related to Hardware (computer and accessories) : specification, component selection, test (including electrical safety and electromagnetic compatibility)
● Manage the technical relationship with suppliers for all product- and R&D-related support material of software
● Establish the system's performance framework
● Identify and monitor technical risks. When needed, work with Software, Data Science Teams to conduct technical feasibility studies.
● Ensure regular Technical Design Reviews are conducted.
● Work with the management team to drive the project per roadmap with given resources.
● Negotiate feature trade-off when needed.
● Working with Regulatory team, implement system risk management activities (Risk identification, Assessment and Mitigation) and support Usability activities.
● Provide all required documentation deliverable and regulatory artifacts
● Develop a transversal and long-term vision for the system, providing inputs for strategic technology decisions
● Contribute to the creation of intellectual property

Profile

    • Graduate from a master’s / engineering school (BAC + 5)
    • Minimum 5 years of experience in the field of complex medical devices containing software and hardware
    • Experience in developing innovative products (prototypes, pre-industrialization)
    • Mastery of medical normative standards ISO 14971, 21 CFR 820, IEC 60601-1, IEC 60601-1-2, IEC 62366-1
    • Knowledge of causal analysis methods
    • Industrialization and post-market experience
    • Fluency in English
    • Excellent communication and synthesis skills for decision-making
    • Team player attitude
    • Leadership and Influence skills
    • Proactivity
    • Analytical skills for problem solving
    • Customer and product culture in the medical field
    • Flexibility and open-mindedness in a changing/innovative context
Why should you join?
AI is revolutionizing healthcare and we are at the forefront of this revolution.
You will get an opportunity to understand the systemic challenges and the areas of impact that AI can have in healthcare,
You will get an opportunity to work with a highly diverse, motivated, and experienced team,
Opportunity to experience the Mediterranean lifestyle. It is great if you enjoy nature and the sea ! 

Additional Information
The position is on CDI, based in Marseille 6th (on the 17th Floor of a Tour Méditerranée). 

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