System Engineer

Details

  • Category: Medical devices
  • Location: Basel area
  • Starting date: Dec 02, 2019
  • Domain of experience: Software architecture; system engineering; SaMD
  • Level required: Mid-senior level
  • Years of experience: 5+

Your Role

In this role you will be supporting our clients in Pharmaceutical and Medical Device Industry in the development of software as medical device (SaMD) projects using pioneering system engineering practices. You will work with cross-functional teams and support different development activities such as system conceptualization, requirement definition, verification, risk assessment and clinical validation.

Your Tasks

  •  Apply system engineering approach in the development and/or life cycle management of complex products and platforms (connected drug delivery devices, wearables and SaMD)
  • Display strong technical knowledge at system level and lead the product development team with the use of system engineering approach
  • Use system engineering tool in requirement management and further translate user/business needs into system and sub-system requirements
  • Constantly monitor and maintain the traceability (requirements to the verification activities)
  • Act as system engineering SME in the communication with stakeholders, teams and programs from different departments
  • Manage suppliers for products development and lead the technical discussions with external vendors
  • Compile DHF files and GMP compliant documents

Your Profile

    • Bachelor/Master Degree in Computer Science, Biomedical Engineering, System Engineering or another relevant field
    • Minimum 5 years of experience in Medical Device, Pharmaceutical or Diagnostics Industry
    • Prior experience in the development of SaMD (from conception to commercialisation)
    • Strong knowledge of Quality Management System and regulatory processes (ISO 13485; IEC 60601, 62304, 82304)
    • Experience with research and prototyping (PoC)
    • Experience with cybersecurity and traceability management tools is highly desirable
    • Previous knowledge of Cloud/IoT architecture and technologies for complex systems
    • Good understanding of Agile, V-Model, CI/CD, Automation, Requirement Management
    • Knowledge of Software and System design with application of UML diagrams
    • Expertise in Web/Mobile application development and testing
Print PDF

RECEIVE OUR JOB ALERTS

DO YOU KNOW THE IDEAL CANDIDATE ?

Help us find the perfect candidate and receive a reward Send to a friend Alert a potential candidate about this opening