R&D Senior System Engineer - Medical Device - Liège
You are looking for a professional challenge that allows you to work in a start-up environment in order to participate to the development of a product with huge potential?
You want to bring your expertise in system engineering and work with talented people? You want to endorse polyvalent responsibilities in order to contribute to build the next generation of the product?
Plus One can offer you this great challenge.
Our Client is a is an innovative early stage medical device company based in Liège. They are developing a cryotherapy system to treat patients with coronary artery disease that is prone to cause heart attacks. The mission of the company is to develop and market the novel cryoenergy therapy for patients that have suffered a heart attack or patients at risk.
To face the growing activities, our client is looking for a Senior System Engineer who will be responsible for system integration design which incorporate electromechanical, fluidic and software elements.
Drive design, testing, system build/installation, and validation of effective instrumentation, test, and control systems to achieve volume scale and cost target requirements
Ensure system data output is aligned with manufacturing process workflows, and validated to meet quality and regulatory requirements
Determine equipment/process specifications through collaboration with internal resources and external vendors as required
Ensures adherence to EU and US regulations for systems validations and electrical safety standards
Provides support for supplier evaluation, as well as for contractual, commercial, supply, quality, manufacturing as necessary
Modify existing software/hardware/firmware to correct errors, allow it to adapt to new hardware, or to improve its performance
Direct code development, software testing, and documentation when appropriate in accordance with current procedures, international standards, and FDA regulations
Collaborate with other departments to ensure manufacturing/test systems meet Quality, Regulatory, and Production requirements
Ensure compliance with internal and external regulations and protocols
Generate clear documentation for use and maintenance of the systems
Write sound engineering protocols for use in system development; collect/ analyze data; write reports
Master in Electromechanical, Mechanical, Electrical, Biomedical or System Engineering.
7+ years experience in development and integration of instrumentation, test, and control systems
Experience with design controls, software and hardware development in a medical regulated environment
Experience at the system level architectural design, performance and characterization
Experience with micro controller development in C and C++, software development and direct code development as well as software testing is a plus
Working knowledge of safety testing requirements and related elements of IEC 60601 & IEC 62304 and other applicable standards
Working knowledge of EU guidance for Computer System Validation and Data Integrity. Knowledge in FDA guidance is a plus.
Labview and/or PLC programming
AutoCAD or Solidworks with experience in fluid delivery mechanisms and systems is a plus
Outstanding collaborative and excellent written and verbal communication skills and good computer skills are required
Good inter-personal skills, ability to work with vendors, outside research groups and potential customers
Our Client offers a full-time permanent position along with an attractive remuneration package.
The position is based in Liège (Belgium) and has an international scope.
This is an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and team spirit.
Visitors of this page also checked out these jobs: