System Engineer

• Root cause analysis of in-service problems (including operational/safety hazards, parts obsolescence, reliability degradation, field issues, compliance issues, regulatory changes), development of required design changes (ECOs) to resolve those issues.
• Design improvements to improve product field performance or to improve product gross margin. Receive field and production feedback and drive ongoing product improvements, identify opportunities for performance and capability enhancement.
• Interact with New Product Development (NPD) teams to ensure appropriate design inputs/ outputs have been taken into account based on predicate product/field data.
• Support the integration of acquired assets within the laser franchise.
• Provide technical assistance for sales and marketing activities.
• Take major role in problem solving and escalations from customers and within the organization.
• Work in collaboration with Regulatory team to provide and maintain the regulatory design inputs and systems compliance. Own the transfer from regulation/standards to engineering derivatives (impact assessment and deployment).
• Support RA team with new markets registrations and regulatory submissions.
• Definition, writing and management of Design Inputs and flow down for the sustaining products.
• Work with program managers to create and manage project priorities and schedules.

Requirements

• BSc in Electrical Engineering, Electro-optical Engineering, Mechanical Engineering, Bio-medical Engineering or Computer Engineering from a leading university. Master degree - advantage.
• At least 3 years of experience in system engineering in multidisciplinary projects (HW, Mechanics, SW and Physics).
• Interpersonal skills and excellent teamwork - the ability to meet technical as well as human challenges
• Experience in medical devices' quality system, specifically is Risk management file and Design Inputs.
• Experience in resolving complex system issues and be “hands on” when needed.
• Fluent in Hebrew and English
• Good documentation skills
• Experience in EMC and Safety certifications
• Experience in Imaging / Electro-Optical systems - advantage.
• Experience in a global company – advantage

[653361]