SYSTEM ENGINEER
The System engineer will contribute to designing, developing, and validating robotic medical devices, ensuring regulatory compliance. Working closely with hardware, software, and clinical teams, the engineer will help deliver innovative robotic solutions to improve patient care.
LOCATION
Montpellier, France
EMPLOYMENT TYPE
Permanent
What You’ll Do
Under the supervision of the R&D Manager, the key missions of the System engineer are:
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Work with a cross-functional team to drive the design and development of system features
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Pilot collaborations with external contractors related to system design
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Conduct design reviews, propose innovative solutions, and identify and reduce product risks
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Resolve requirements conflicts, and ensure requirements traceability
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Define system specifications, taking into account technical and functional requirements
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Write quality documents related to product design and development in compliance with applicable standards and procedures to ensure product quality and safety
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Write and review test protocols and reports
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Execute functional tests and write the resulting test reports
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Work closely with the engineers to reproduce, characterize and trace identified defects
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Supports the regulatory team in establishing the documentation for CE, 510k certification
Who You are
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MS in engineering / science or equivalent degree
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4+ years of experience in R&D product development and a strong belief in quality compliance
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Ideally a previous experience in medical devices for CE certification/FDA
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Knowledge in medical device environment IEC62304, ISO13485, ISO14971, ISO62366, etc
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Enthusiasm and a strong desire to improve surgical technology
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A proactive personality with the ability to integrate with the existing start-up team
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Ability to listen and be a team player
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Excellent organizational, collaboration, communication and analytical skills.
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A proactive personality with the ability to integrate with the existing start-up team.
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Ability to listen and be a team player.
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Ability to learn and adapt quickly to a rapidly evolving work environment.
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Excellent oral and written communication skills in English (work language) and French.
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Acusurgical is an equal opportunity employer and values diversity in our workforce.