Design Transfer & Pilot Production Leader 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 and working closely with other departments, your mission will
be to lead the transfer to production of the design output of R&D, as well as maintaining safe and
efficient operations of pilot-scale medical production of our device.

Reporting to the VP of Engineering, you will:

● Define and implement compliant design transfer and production activities under applicable regulatory and normative requirements
● Define, maintain and implement industrialization methods and production processes compliant with the regulation
● Collaborate with R&D experts during the design and development phase to ensure production and serviceability requirements are taken into account
● Maintain and deliver compliant DMR and DHR and associated records with Quality and Regulatory teams
● Research and validate new subcontractors or suppliers necessary for the production of all or part of the products
● Manage component obsolescence
● Define production equipment, measurement equipment and associated controls
● Control the compliance of production processes and equipment with reference standards or specifications
● Analyze post-market product issues to ensure proper production adjustments
● Develop and maintain a precise production plan (team, space, equipment and supplies) based on company needs to meet short-term and long-term goals in partnership with the R&D team
● Supervise daily pilot production operations including but not limited to; establishing project plans, assigning tasks and identifying potential bottlenecks, and ensuring the safety and maintenance of the production area
● Develop and maintain production best practices, quality standards of raw materials and products, and operational documentation (DHR, SOPs, records, process descriptions and QC processes) compliant with the regulations and quality standards
● Ensure compliant packaging and shipping of finished products

Profile

    • Graduate from a master’s / engineering school (BAC + 5)
    • Minimum 3 years of experience in the field of medical devices production containing software and hardware
    • Experience in transferring innovative products to production
    • Mastery of medical normative standards 21 CFR 820.30(h), 21 CFR 820.181 (Subpart M), ISO 13485 and Good Manufacturing Practices guidelines
    • Project Management: Ability to manage multiple projects and prioritize effectively to meet deadlines.
    • Communication: Ensures that all necessary information is passed on to stakeholders and teammates.
    • Analytical thinking for problem solving: The ability to tackle a problem by using a logical,
    • systematic, sequential approach considering implications and preparing for possible
    • contingencies.
    • Self-Management: Ensuring that one’s own work meets expectations.
    • Proactively solicits and provides feedback to improve self and team performance.
    • Industrialization and post-market experience
    • Fluency in English
    • Pragmatism (technical risk, cost, delays, downstream impacts, etc.)
    • 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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