לוח משרות דרושים רפואה ופארמה

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.