Primary purpose and function of this position:
The Software system Engineer primary purpose is to integrate the design and development activities of the SW development team, through the full life cycle
of the product according to the different project stage.
Activities
will focus on leading an agile development of a cross functional team of designers, development and testers, and hold all SW system level documentation %28including
establishing requirements and assessing the suitability %28risk, compliance%29 of current designs and technologies to meet the requirements%29.
Major duties and responsibilities:
· Have a full and whole understanding of the system and SW design and requirements.
· Own the software technical requirements in compliance to with standards and regulatory guidelines.
· Support development cycle: from user needs, requirements, design, implementation testing and release of the products.
According to the SW life cycle management, FDA and CE regulation.
· Support characterization and development of SW tools for R&D testing and production.
· Hold SW documentation and assist with QA processes in DCS.
· Integrate and collaborate between SW team members, other R&D functions, subcontractors and other key functions.
· Provide software support and assistance during usability studies, preclinical labs and/or manufacturing processes.
Education and Knowledge Requirements:
· Eng. degree SW engineering, Electornics or Biomed.
· Minimum of 3+ years of relevant experience with oversight of SW development of multidisciplinary product.
· Experience in medical device software- advantage.
· Excellent oral and written communication skills in English.
· Knowledge of IEC 60-601-1-8, 60-601-2-24- advantage.
· Knowledge of cloud server architecture, iOS and Android applications- advantage
