Position
The system eng. Manager will report to the R&D manager. It will be key player in a multi-disciplinary development team. Will lead the system engineering team and activities. Plan the SE day to day activities to meet the project goals. Support product development strategy and life cycle management, including technical, regulatory and in field support.
Proactive approach toward products development, team building, collaboration with stakeholders and key members.
MAJOR RESPONSIBILITIES
Provides management leadership to the system engineering team. Lead the team activities to meet the project timelines. These responsibilities include:
• Managing system engineering activities
• Lead the system engineering team
• Lead and execute risk management and risk analysis according to the project plan, design updates and according to company procedures.
• Documenting system level documentations: product requirements, risk analysis and project constraints.
• Defining and leading system architecture, system and sub system development.
• Overseeing and technically leading verification and validation planning, execution, and reporting efforts.
• Leading the team and the product through regulatory compliance activities.
• Ensuring efficient and complete transition from definitions to scale up.
• Lead technical discussions with regulatory authorities
This position is also tasked with supporting current development efforts including planning technical aspects of projects, developing our capabilities, interfacing with current and prospective stakeholders, and participating in conferences. And travelling (once possible) to production sites and consultations.
THE FOLLOWING IS REQUIRED
• Bachelors Degree in engineering discipline relevant to product development (e.g. mechanical, electronics, SW).
• 7+ years of new product development experience, with at least 3 years in medical products.
• 5+ years of management (project/ team leader) in multi-disciplinary company.
• Demonstrated track record of successful product development on dynamic projects.
• Proven abilities in leading cross functional technical teams, managing risk, and adapting to change.
• Team player and a problem solver who demonstrates knowledge of fundamentals but also the big picture.
• Excellent communication skills (Hebrew and English) to support interaction with cross-functional team members, regulation, quality assurance and marketing.
THE FOLLOWING IS DESIRED
• Experience working under an ISO 13485 registered quality system.
• Experience registering products through FDA regulations (such as 510(k)).
• Experience with ISO 14971 and/or experience in conducting safety risk management activities (e.g. Hazard Analyses, FTA, and various FMEAs).
