System Engineer (Medical Device Software)

Brief:

Novodes invites applications for the role of System Engineer in an ongoing collaboration with a multinational medical device company. This role is based at the client's offices in Rehovot, near the train station, and offers hybrid working conditions with two days of remote work each week.

Role Description:

The System Engineer will specifically lead the software development aspects of a multidisciplinary medical device project, focusing on the integration of software design and development activities throughout the product lifecycle. This position is part of a larger team where each member is responsible for different segments of the software, ensuring a collaborative approach to complex project demands. This is not a managerial role.

Major Duties and Responsibilities:

• Lead the software component of a multidisciplinary medical device project, focusing on high-quality software integration into the overall product.
• Manage and enhance Design for Manufacture and Assembly (DFMA) processes specific to software integration.
• Perform in-depth System and User Risk Analyses to identify and mitigate potential risks in software design and functionality.
• Maintain rigorous documentation and traceability for all software development activities, adhering to the Software Development Life Cycle (SDLC) processes of medical devices.
• Champion cybersecurity measures and manage risk assessments, including Ufmea, Dfmea, and OTS evaluations.
• Collaborate with a team of project managers, software engineers, software testers, and the V&V team, each responsible for different software aspects, to ensure cohesive and efficient development practices.
• Foster agile development methodologies among the software team, utilizing tools such as Jira for project management.

Reports To:

Head of Software and Digital Development

Competencies:

• Excellent analytical and strategic thinking skills.
• Strong communication skills, capable of working collaboratively and independently.
• Problem-solving attitude with a solution-oriented approach.

Education and Knowledge Requirements:

• Engineering degree in Software Engineering, Electronics, or Biomedical Engineering.
• Minimum of 5 years of relevant experience in software development management within the medical device field.
• Thorough knowledge of Agile methodologies and experience with Jira.

Advantage:

• Experience working according to IEC 60-601-1-8 and 60-601-2-24 standards
• Familiarity with cloud server architecture and mobile applications (iOS and Android).
• Experience with cyber security.

Travel Requirements:

• Up to 10% international travel may be required.

About Novodes:

• As a leading contract development firm, Novodes specializes in software development services for the medical device industry, providing turnkey solutions to a broad range of clients, from startups to NASDAQ-listed companies.