Ethosia
- 12/10/2023
- יקנעם עילית
- 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]
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