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System Engineer H/F
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Annonce N°48098Publié le 22/08/2022 à 04:41
Description
Montpellier (France) WHEN: ASAP CONTRACT TYPE: Permanent Contract
(CDI) * EDUCATION: MS or PhD in Engineering or equivalent. *
EXPERIENCES: 5+ years of experience experience in an industrial
environment with broad exposure to hardware / software / system
design. * DESIRED EXPERIENCES: An experience in an industrial
environment requiring knowledge of applicable regulations and
standards (ISO, IEC, FDA). JOB SUMMARY SYSTEM ENGINEER H/F COMPANY
DESCRIPTION Co-founded in 2017 by Bertin Nahum, Quantum Surgical is an
innovative surgical robotic company which develops a unique
mini-invasive surgery solution dedicated to liver cancer treatment by
percutaneous ablation. Our platform combines robotics, image
analytics, and artificial intelligence to enable physicians to better
plan, treat, and evaluate their interventions. This pathology is the
second deadliest cancer and affects 840 000 persons each year in the
world. JOB DESCRIPTION We are looking for a SYSTEM ENGINEER M/F to
join a team of creative and energetic engineers who are building the
next generation of smart tools for minimally invasive therapies. The
System Engineer is involved for the design and development of new
product technologies or features to fulfill unmet user needs. He/she
will bring his/her expertise to ensure the delivery of a high quality,
reliable, manufacturable, serviceable, and compliant product. The
candidate should have demonstrated experience in a system engineering
or equivalent role for the design of complex systems within a
regulated environment. He/she will focus on innovation, performance,
and safety. He/she will interface with engineers (Software, Robotics,
Mechanical, Electrical, Test), Quality/Regulatory as well as Project
Management, Marketing and Clinical teams. Your missions will be the
following: * Work cross-functionally and participate to the design &
development of product features * Interact closely with the Lead
System Designer to perform adequate system engineering activities all
along project activities * Interact with marketing & clinical teams to
define product technical requirements * Participate in the risk
management and usability engineering activities * Participate to
design reviews and reduction of main technical risks together with
Subject Matter Experts * Participate in conflicting requirements
resolution and requirements traceability * Review software and
hardware product specifications to ensure effective flow down from
system requirements * Participate to the product architecture
specification balancing implementation complexity, risks,
manufacturability, serviceability and quality * Participate to the
development of test methodologies and test systems to ensure product
performance over all intended use and stress conditions. * Participate
to the production of Instruction For Use related to the company’s
products * Support the Test Engineers for verification activities *
Participate to the validation activities and production of related
deliverables * Support the design transfer & manufacturing teams to
establish the device DMR * Support the RA team to establish the
regulatory filings (CE, 510k, etc.) * Support the QA Team to handle
design changes, product complaints, non-conformance, CAPA, post market
surveillance, audit findings. PROFILE * You have an MS in Engineering
or equivalent. * You have an experience in an industrial environment
with broad exposure to hardware / software / system design. * You have
a technical expertise in one or more engineering disciplines. * You
have an experience writing requirements and design specifications. *
You are pragmatic, customer focus approach. * You have solid
analytical and problem-solving skills. * You are self-motivated,
curious and open-minded. * You have excellent communication and
documentation skills. * You are able to work across functions and team
boundaries. * You are highly proficient in oral and written English. *
Ideally, you an experience in an industral environment requiring
knowledge of applicable regulations and standards (ISO, IEC, FDA). *
Ideally, you are familiar with design controls in an FDA regulated
environment. * Ideally, you have experience with Agile development
methodology. WORKING AT QUANTUM SURGICAL MEANS * Joining a talented,
dynamic, and multicultural team whilst being part of the technological
and human adventure of a company in full evolution. * Sharing our
culture of innovation, team spirit and result-oriented * Taking up
technical challenges * Benefiting from a competitive compensation
(fixed salary + variable, BSPCE)