Are you looking to continue a long-term career at the heart of the Medical Ultrasound and Medical devices sector ?
Experienced in Systems Engineering within R&D , analysing user needs to convert them into technical requirements and system level architecture design ?
If so,our client , a renowned innovator in healthcare technologies that enable women to live healthier lives every day is currently looking for an experienced Lead Systems Engineer to be based in their Aix-en-Provence office in the South East of France.
This is an excellent opportunity to join an expanding local team in an office based position within a truly international organisation, applying strong cross-functional engineering skills and technical leadership coordination experience to successfully deliver new Ultrasound Medical Systems and Devices that will benefit patients globally.
The Lead Systems Engineer gathers and analyses user needs to translate them into technical requirements and systems level architecture design. He /she also plays an essential role in driving the technical effort , respecting time , reliability, performance and regulatory constraints through fully understanding all the stakeholders and functions involved in the design and development of a system.
Please see below for further details of this new challenge !
*Lead the design core team and design control process from requirements gathering to the design transfer.
*Drive teams in technical design and production , ensure the good understanding of requirements , designs and risks.
*Translate user requirements into high level technical requirements.
*Breakdown features, organize functions , identify relationships ( interfaces) between systems/features and propose architecture.
*Lead the design core team through the verification and validation execution.
*Lead the collaborative efforts with cross-functional ( Electronics, Software, Hardware) Leads to create and maintain instrument architectural designs.
*Ensure systems consistency and serviceability.
*Contribute to risk identification and assessment.
*Ensure all technical documents are delivered on time with desired quality level
*Review and create Design History File (DHF) deliverables per New Product Introduction (NPI) plans as required by the Quality Management System.
*Educate R&D teams to system engineering good practices.
Skills and experience required
*A Master's degree in Engineering with a strong understanding of software development is required.
*Significant long-term experience related to systems engineering within a manufacturing company the medical device sector.
*Proven experience in cross functional activities ( software , mechanics, electronics, hardware) in the medical device field.
*Proven ability to work with technical leadership to implement a complex system.
*Excellent knowledge of quality and regulatory standards related to medical devices development (ISO 13485, ISO 14971, ISO 62366, IEC 60601, …) with proven record in dealing with CE marking and 510k FDA registration.
*Excellent knowledge of the development cycle in the medical device field
*Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc)
*Excellent communication skills
*Fluent in French with very advanced or fluent English.
*Analytical, relatable and responsible.
*Demonstrated experience in driving teams/project
*Able to work with dates, milestones
*Knowledge about system engineering best practices
*Ability to evaluate the business implications
*Understands technical constraints with medical devices, specifically relating to Electronics, Mechanical , Software devices.
*Eager to learn, to interact and to educate.
*An organised , structured and process driven attitude.
Beneficial skills and experiences
*Imaging sector experience or experience within the Medical devices industry.
In return our client can offer an enriching , stimulating and challenging opportunity within a renowned and leading medical devices organisation making a real difference to the lives of women worldwide. You will join and innovative and inspiring business , taking the lead role on a team of 3 people, set to grow to 5 this year. You will continually receive opportunities to learn , grow and develop your career.
If this sounds like a medical devices opportunity that would allow you to apply your passion and interest in medical devices and ultrasound then please do apply today !