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we are seeking for a V&V Engineer, to join the QA, RA & CA department.
As a V&V Engineer, your principal task will be to verify and validate Medical Devices. You will be responsible for HW & System testing including test protocols and reports.
The main responsibilities within this role:
Design, develop and execute system Verification and Validation test procedures.
Responsible for writing detailed, comprehensive, and well-structured V&V test protocols and reports ensuring requirements coverage and traceability.
Analyzing issues and failures in the system.
Work in a highly multidisciplinary and complex technical environment and lead testing of cross-functional projects (with emphasis on mechanical and electro-optical aspects)
Being involved in the reliability and integration tests for prototypes under development
Coordination and management with external testing laboratories
Define and maintain the Verification & Validation plans.
Plan and arrange the work, schedules, and equipment required for testing and evaluating standard and special devices.
Identify, investigate, and document all findings raised during testing.
Work closely with cross functional team members including R&D (System, SW&HW), QA, RA and Product departments.

Mechanical Engineer within the Urology Division will be responsible for providing support for released products within the Laser Franchise, which consists of Holmium and CO2 laser capital systems, laser fibers and associated accessories.

Mechanical Engineer works in close collaboration with the different technical disciplines (Elec, Mech, SW, Physics), as well as the other cross-functional groups (Quality, Regulatory, Manufacturing, Service) to support sustaining activities as part of Product Life Cycle.

Mechanical Engineer supports growth of products to new markets and leads design changes originating in product improvements, regulatory or supply chain needs.

Main Duties:
Conduct root cause analysis of design related field complaints.
Lead product improvement design activities.
Provide technical assistance for sales and marketing activities.
Support the integration of acquired assets within the laser franchise into the company`s Scientific quality system.
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.

The System Engineer Architect will play a key role in designing, developing, and optimizing advanced laser optical systems for Urology, as well as supporting ongoing activities as part of Product Life Cycle, while working in close collaboration with the lead Sys Eng., the different technical disciplines (Elec, Mech, SW, Algo), and other groups (RA, QA, Mfg).

Main Duties:
Support technical characterization and system design of cutting-edge laser systems.
Lead the architectural design of laser systems, including Tx-Rx design and SNR optimization, to meet performance specifications and customer requirements.
Conduct system-level analysis, simulations, and modeling to evaluate and validate system performance under various operating conditions.
Lead problem solving and escalations of system-level issues, proposing, and implementing effective solutions.
Understanding the range of user, product, business and marketing requirements, and work in collaboration with Sys Eng. to convert them to practical system level requirements.
Lead integration and lab experiments in collaboration with cross functional teams to validate and optimize system functionalities.
Analyze system performance data to derive meaningful insights and recommendations. Implement data-driven improvements.
Lead design reviews, project meetings, and technical discussions to communicate progress, challenges, and recommendations effectively.
Stay current with emerging technologies and industry trends in laser systems and signal processing and provide recommendations for technology adoption and innovation.
Mentor and provide technical guidance to junior engineers, fostering their professional growth and development.
Drive excellence, innovation, and efficiency in system design processes, ensuring reliability and performance meet the highest standards.