In this role, you will lead technical activities in support of the design and development of multi-disciplinary medical devices for proprietary products. The position requires knowledge and experience in system characterization, modeling and analysis. This role has frequent interaction with global functions including R&D, Quality, Regulatory Affairs and other key functions, internal and external stakeholders and management to achieve business deliverables
Essential Duties and Responsibilities:
Manage and lead the technical activities of a project and examine solutions based on functionality, quality and cost.
Implement Systems Engineering best practices for methodology, attend Systems Engineering training, and conduct necessary training for R&D staff as methodology is established.
Utilize knowledge and experience to perform scientific studies using various lab equipment.
Characterize system and/or sub-system inputs, outputs and functionality, utilize analytical skills and
simulation tools to define appropriate product specifications
Key point of contact for technical product related interactions and discussions. Provide technical
expertise and communication.
Collaborate globally with other functional groups %28R&D, Regulatory, Quality, Operations, etc.%29
and customers during the product development process as well as throughout customer acquisition
and adoption.
Mentor and guide junior system engineers.
Responsible for assuring all design control process and documents follow the Company QMS
Keep manager advised of all work status, workload, problems, and progress as related to work
assignments. Prepare project plan, schedule, budget, and interim reports
Improveprocessesandprocedurestodevelophighqualityproductsataminimumcost.
Performotherdutiesasassignedbasedonbusinessneeds.
Basic Qualifications:
Education – Bachelor’s degree in Biomedical, Material Science, or related Engineering field required
Ten %2810%29 or more years of related work experience
Proven experience in system modeling and characterization
Preferred Knowledge, Skills and Abilities:
Extensive hands-on design experience with test set-up, and lab simulation tools
Must be proficient in Hebrew and English
Ability to present in front of an audience, accommodating shared information to match the applicable
audience
Background in R&D of electromechanical medical device involving software is an advantage
Familiarity with ISO-11608, IEC-60601, IEC-62304, ISO-14971 is an advantage
Skills: Team player, excellent communication skills, responsible, creative, organized, able to work in a
dynamic environment
Travel Requirements:
• Must be able to travel up to 10-20 % of the time
Competencies/Authorities
Ability to manage multiple priorities with high flexibility and rapid response time
Demonstrated ability to exercise independent judgment in making decisions and resolving complex problems related to general & technical aspects of the product/program. Decisions made with in-depth
understanding and interpretation of procedures, policies and business practices to achieve results
Mentor junior engineers and/or analysts
