Medical Device Systems Engineer

Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.

Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics, and Fractures Treatment.

For our R&D Department, we are looking for a MEDICAL DEVICE SYSTEM ENGINEER



  • Contribute to medical device development projects in a multidisciplinary technical environment (mechatronics, electronic systems, active devices, motorization, wired wiring, printed circuit board, embedded software, functional and regulatory testability)
  • Define, coordinate and document the functional and regulatory test plan, write protocols, test reports and risk analysis
  • Ensure device compliance with applicable regulatory requirements EU MDR 2017/745, ISO 13485, ISO 14971, IEC 60601, IEC 62366 and 21CFR Part 820




Project definition

  • Contribute with the Product Manager to the establishment of the specifications by translating the needs into functional and technical specifications 

Product Design and Development

  • Coordinate the different expertise involved in the project (electronics/software/mechanics/tests) internally or outsourced
  • Define and document the System design (procedures, wiring, nomenclature, etc.)
  • Comply with the project schedule, respect or enforce the requirements of the specifications, objective costs, performance and quality standards
  • Manage the manufacture of prototypes and test devices, in conjunction with the various manufacturers 

Verification and validation of the Product

  • Define the functional and regulatory test plan, develop test methods and tools, execute or monitor tests (functional and reliability tests, electrical safety, etc.) to validate the design
  • Participate in the development and lead System integration (including reliability tests) by conducting technical investigations
  • Write documentation, including Test Reports, in accordance with regulatory and Quality requirements
  • Contribute to the creation and maintenance of the design file (DHF) of the project 

Industrialization of the Product

  • Support the industrialization of new products and define control points
  • Ensure that the manufacturing system and procedures comply with regulatory requirements 

Product Life Cycle Management

  • Contribute to the NPI (New Product Introduction) process and continuous product improvement      


Profile resquested

  • Diploma in mechatronics, with skills in robotics, electronics, power supply, automation and mechanics
  • Experience of development projects in highly regulated environment and 3 years minimum in medical, with good knowledge of IEC 60601 and its annexes
  • Experience in testing electronic systems and managing medical device test campaigns with on-board electronics (a plus: test program coding or bench design or laboratory experience)
  • Experience in reading electronic schematics and using laboratory instrumentation
  • Familiar with EMC (and if possible electrical safety) and certified organizations. Experience in setting up the technical file (in technical assistance to the regulatory affairs/quality teams) during the preparation of the CE marking and/or FDA approval is necessary.
  • Very good oral communication and excellent writing skills
  • Written and oral proficiency in professional English
  • Inventive, rigorous, meticulous, analytical skills, problem solving and optimization of electromechanical systems, decisiveness and curiosity, interpersonal skills and sense of multidisciplinary work
  • Adaptation and organizational skills
  • Knowledge of surgical motors, medical imaging systems, robotics and navigation would be a plus
  • Knowledge of IEC 62304 is a plus