Senior Software System Engineer - Medical Device

The Senior 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.

Education and Knowledge Requirements:

• Eng. degree SW engineering, Electronics or Biomed - Must
• Experience in medical device software- must.
• Minimum of 5 years of relevant experience with oversight of SW development
• Previous experience with Agile methodology – preferred through Jira. 
•   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

Competencies:

• Good analytical skills
• ·Solution-oriented and problem solving attitude.
• ·Strong communication and organizational skills.
• Teamplayer who can also operate alone.

Travel Requirements: up to 10% International Travel is required.

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.
• Identifies problems and leads the effort to solve software issues.
• 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.
• Contribute to the assessment of proposed design changes and impact based on test evidence.
• Full involvement in risk management activities (cybersecurity, Ufmea, Dfmea and OTS assessment)
• Provide software support and assistance during usability studies, preclinical labs and/or manufacturing processes.