Requirements:
Required Qualifications:
BSc in System Engineering/Electrical Engineering/Electro-optical Engineering/Mechanical Engineering/Bio-medical Engineering/Computer Engineering. MSc - advantage.
At least 8 years of experience in development of multi-disciplinary products, including HW, Mechanics, Software and Physics.
Experience in Tx-Rx systems and signal-to-noise design.
At least 4 years of experience in System Engineering.
Communication and technical status reporting skills
Interpersonal skills and excellent teamwork.
Experience in leading resolution of complex system issues, including hands on work.
Fluent in Hebrew and English.
Experience Electro-Optical systems - advantage.
Experience in Medical devices - advantage.
Experience in a global company advantage.
Knowledge of optics / laser - an advantage.

Requirements:
Ensure the proper implementation of the SDLC process according to IEC 62304, the quality of the documentation (review and approval ) in the project, that is compliance with the regulatory requirements
Support SW production/release documentation and ECO
Provide Quality support at various stages of Product Development and coaches others in analysis and decision making
Ensuring that R&D procedures and work instructions are continuously up-to-date and effective
Lead Risk Management processes according to ISO 14971
Provides the quality/independent review at defined design reviews and project design plans, for new development projects as well as design/process changes
Support the implementation of eQMS systems and quality tools used in the development process, including documentation, testing, and monitoring of the product
Keeps up to date on all ISO/FDA/MDR and other Product Development related regulatory requirements and relays this information to the Product Development group
Qualifications:
Bachelors degree in Engineering or related field, such as Engineering, Computer science, etc
5 years of related experience in the medical device, experience with the development of Multidisciplinary products or SaMD
Expert understanding of appropriate global medical device regulations, requirements, and standards, including Quality Management System ISO 13485/ QSR / MDR, SDLC IEC 62304, and Risk Management ISO 14971
Familiar with cybersecurity and privacy standards and regulations, such as ISO 27001:2013 an advantage
At least 5 years of experience as a QMS Specialist/Manager
Certified Quality Engineer (CQE / CQM) an advantage
Certified Internal Auditor an advantage
Project Management (development of project plans, status meetings, project reporting, etc) and organizational change movement
Ability to communicate perfectly in English both orally and in writing
Self-motivated and able to manage time working on multiple projects simultaneously
Tech Savvy Demonstrated competency in computer skills
Must be able to communicate appropriately and adequately to all management levels

Requirements:
At least 7 years experience as a Project Manager of multidisciplinary products
Significant experience in Waterfall and Agile processes and project management methodologies
Familiarity with project management tools, including Monday.com, MS Project and Azure DevOps, PMBOK and Scrum methodologies.
Proven ability to lead and motivate teams, deal with challenges and maintain efficient cross-organizational communications.
Working with Mass Production Units, subcontractors and vendors
Experience working in matrixial organizations, interfacing with Systems Engineers, R&D Team Leaders and Product Managers
Representative, ability to present projects reviews in both Hebrew and English
Excellent interpersonal communication skills
Analytical, organized, process-oriented, great attention to details
Highly motivated, initiator, proactive, multitasker, ability to work under pressure
Familiarity in software, hardware, firmware, mechanics, or radio development advantage
Education:
BSc in engineering, technological management, or industrial management. MSc advantage