PlusOne

R&D Senior System Engineer - Medical Device - Liège

About PlusOne

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.

Company

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.

Job Purpose:

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.

Role

  • 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

Profile

  • 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

Offer

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.

Publication date

07.08.2020

Contact person

Caroline Franki

All vacancies
Plus One uses cookies to remember certain preferences and align jobs interests.