לוח משרות דרושים

we are seeking a Senior Design Quality Assurance Engineer for our Urology division. This role involves developing, supporting, and managing risk for Medical Electrical Equipment/Systems (MEE/MES) and related accessories as part of New Product Development. Become part of a team shaping the future of the operating room, with a focus on advanced kidney stone treatments and innovative solutions for physicians and patients. Lead the development of safe, high-quality products and make a direct impact on patient care and clinical outcomes.

Your responsibilities include:

Lead product teams within the BSC Quality System to develop new MEE and MES as part of a core group of DQA Engineers supporting the Laser Therapies franchise. Special focus on:
Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
Utilize Systems Engineering practices to lead efforts for requirements management/system architecture to align risk mitigations with design inputs, design outputs at different levels (e.g., system / sub-system) for products that are both stand alone, and network connected.
Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
Lead Risk Management activities during all phases of Electrical HW/SW design, using design quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
Participate and lead in the creation and maintenance of Risk Management and Usability deliverables.
Lead and/or support development of NPD Reliability Engineering Program Plans and related reliability program activities.
May perform other duties as directed.

The PCBA Production Process Engineer is responsible for designing, optimizing, and managing the processes involved in assembling printed circuit boards (PCBs).
* Production Support: Troubleshoot and resolve technical issues on the production floor, including soldering defects, alignment errors, or component misplacement. Provide Real-Time Technical Support to operators and technicians during production runs. Ensure proper setup, calibration, and maintenance of equipment like reflow ovens, AOI (Automated Optical Inspection).
*  Quality Assurance : ensuring compliance with IPC-A-610 or similar industry standards. Conduct root cause analysis and corrective actions for defects identified during production. validate assembly quality.
* equipment and Technology Integration: Evaluate, procure, and integrate new production equipment or technologies to improve efficiency and quality. Develop and maintain preventive maintenance schedules for manufacturing equipment. Ensure compatibility and proper usage of consumables like solder paste, stencils, and components.
Country:
Israel
City:
Ziporit