A leading medical devices company is looking for an experienced system engineer!
o 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.
o 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.
o Interact with New Product Development (NPD) teams to ensure appropriate design inputs/ outputs have been taken into account based on predicate product/field data.
o Support the integration of acquired assets within the laser franchise into the Boston Scientific quality system.
o Provide technical assistance for sales and marketing activities.
o Take major role in problem solving and escalations from customers and within the organization.
o 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).
o Support RA team with new markets registrations and regulatory submissions.
o Definition, writing and management of Design Inputs and flow down for the sustaining products.
o Work with program managers to create and manage project priorities and schedules.
o BSc in Electrical Engineering, Electro-optical Engineering, Mechanical Engineering, Bio-medical Engineering or Computer Engineering . Master degree – advantage.
o At least 3 years of experience in system engineering in multidisciplinary projects (HW, Mechanics, SW and Physics).
o Experience in medical devices' quality system, specifically is Risk management file and Design Inputs.
o Fluent in Hebrew and English
o Experience in EMC and Safety certifications
o Experience in Imaging / Electro-Optical systems – advantage.
o Experience in a global company – advantage