Senior System Project Manager (Medical Device Software)

Brief:

Novodes is looking for a Senior System Project Manager (medical device software) to join our team and work on a medical device development project with a multinational medical device company based in Rehovot. Our company has been engaged in this project for over seven years. The work shall be conducted at the client's location in Rehovot, conveniently located near the train station. The role includes a hybrid work option, allowing for two days of remote work each week.

Role Description:

The Senior System Project Manager (medical device software) will primarily focus on integrating the design and development activities of the software development team throughout the full product lifecycle, according to the various project stages.

This role involves leading an agile development team, including designers, developers, and testers, and maintaining all software system-level documentation. This encompasses establishing requirements and assessing the suitability (risk, compliance) of current designs and technologies to meet those requirements.

Major Duties and Responsibilities:

• Gain a comprehensive understanding of the system and software design and requirements.
• Own the software technical requirements in compliance with standards and regulatory guidelines.
• Support the development cycle from user needs through requirements, design, implementation, testing, and release of the products, according to software lifecycle management, FDA, and CE regulations.
• Support characterization and development of software tools for R&D testing and production.
• Identify problems and lead efforts to resolve software issues.
• Maintain software documentation and assist with QA processes in DCS.
• Facilitate integration and collaboration among software 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.
• Provide software support and assistance during usability studies, preclinical labs, and/or manufacturing processes.
• Full involvement in risk management activities, including cybersecurity, Ufmea, Dfmea, and OTS assessment.

Reports To:

Head of Software and Digital Development

Competencies:

• Good analytical skills.
• Solution-oriented with a problem-solving attitude.
• Strong communication and organizational skills.
• Team player who can also operate independently.

Education and Knowledge Requirements:

• Engineering degree in Software Engineering, Electronics, or Biomedical Engineering.
• Minimum of 5 years of relevant experience with oversight of software development.
• Previous experience with Agile methodology, preferably using Jira.
• Experience in medical device software is required.
• Excellent oral and written communication skills in English.
• Knowledge of IEC 60-601-1-8, 60-601-2-24 is an advantage.
• Familiarity with cloud server architecture, and iOS and Android applications is an advantage.

Travel Requirements:

Up to 10% international travel is required.

Company Description:

Novodes is a contract development company that offers software development services to medical device companies. We also provide turnkey solutions to customers ranging from small startups to NASDAQ-listed corporations.