System Engineer

Novocure is a medical device company with R&D Office based in Haifa Israel.

The company is growing quickly as it commercializes TTFields therapy: a novel treatment for aggressive cancers using alternating electric fields.

Novocure develops a new generation of Optune, our medical device as well as software platforms for TTFields treatment planning and more.

We are looking for a System Engineer to help drive the system vision, architecture and design requirements of these multi-disciplinary device and software development projects.

You will be joining a talented engineering team working with new innovative products dedicated to making a worldwide impact on cancer treatments.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop system architecture and requirements of the systems while collaborating with:
• Product development disciplinaries lead and function while considering our legacy products' needs and future roadmap product architecture
• Cross-functional partners with dedicated regulatory and compliance requirements
• Analyze design alternatives from all aspects, such as design complexity timelines and risks, technical and clinical performance, cost, etc.
• Assist the relevant project functions with technical decision-making in the project while collaborating with cross-functional peers within and outside R&D.
• Support project managers to create and manage project work plans
• Design and lead system-level integration and support system testing and validation and verification.
• Ensure the delivery of high-quality products and ensure development according to medical device industry standards.
• Maintain strong communication across departments and divisions to ensure effective development process, requirements gathering, and operational planning in the development
• Prepare all system engineering-related artifacts as per internal PLM and International Medical Development Guidance (FDA, CE, CFDA, etc.)
  
  

• Qualifications:
  
  

• Knowledge:
• Minimum 3 years of system engineering experience in a regulated environment
• Medical – Class II/III devices is an advantage
• Excellent communication skills in English
• At least 1 year of experience with system engineering of medical devices - advantage
• Over 5 years of experience as a development engineer in the field of Software/ Hardware/ Mechanical engineering
• Experience with Imaging systems – advantage.
• Experience working in an Agile/Scrum development process – advantage
• Demonstrated ability to work with technical leadership team to implement new products & technologies, and interfacing with in-house teams as well as remote global teams/contractors.
• Capable of developing high and low-level system requirements based on internal, marketing, technology, and customer inputs.
• Translating higher-level Marketing and User Requirements into technical requirements for Engineering functions
• Capable of partitioning large systems into subsystems and components.
• Creative problem solver and solution developer when presented with conflicting requirements, business demands, and technical risks/issues.
• Strong communication and influencing skills, able to "hold the room" and lead meetings
• Experience in generating a set of acceptance test requirements, together with the designers & test engineers, and experience with quality management, standardizations, and regulations.
• Knowledge and understanding of Medical Device Compliance and Medical standards (60601, 62304, etc.) - advantage
• Previous experience with Medical Regulatory submissions - advantage