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Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking fo r a R&D Mechanical Engineer to join our Mechanical team in the R&D department. Job Description Mechanical design of infusion pumps with a focus on electro - mechanical mechanisms and multidisciplinary devices development. Direct Manager Mechanics Director

we are looking for a Senior Systems Engineer to join the Systems Engineering Team within the Surgical Operating Unit. This role will be focused on definition, integration, and validation of software sub-systems that are part of larger surgical robotic systems. The successful candidate will work with cross functional teams to execute functional decompositions, develop product and sub-system requirements, and define system and subsystem architecture. They will lead or participate in trade-off studies, prototype evaluations, and clinical acceptability studies.
Responsibilities may include the following and other duties may be assigned:

Provide systems engineering excellence and leadership through a products full development lifecycle, from commitment through to product launch.
Understand and translate stakeholder needs to requirements and total systems solutions that acknowledge technical and business constraints.
Analyse use cases, document product lifecycle, and define use conditions.
Oversee the regulated development processes and standards for risk management, usability, and safety to ensure system design and documentation meet relevant safety and regulatory standards globally.
Work with cross-functional teams to ideate, develop and test software subsystem concepts, and develop software subsystem architectures.
Understand, evaluate, and communicate system performance, desired behaviour, and usability in the context of clinical use.
Work with engineers to grasp the technological underpinnings of system architecture and detailed design.

R42331

well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

About the role:
a worldwide and diverse company who puts patients first. Through this position, the ideal candidate would use their systems engineering and risk management experience to support, develop, establish and maintain Medical Electrical Equipment/Systems (MEE / MES) and associated accessories for New Product Development (NPD) Engineering within the Urology Division of (BSC).
Our team is all about building the future of the operating room for Urologists.

As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; To help patients in need get back to their daily lives. As a Principal Design Quality Assurance (DQA) Engineer, youll be at the heart of that mission to develop and support best-in-class products to bring advanced, safe innovations to the clinic. You will also be leading the effort to develop MEE / MES. Your contributions will directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.

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.

* Support MRgFUS neurosurgical clinical programs in Exablate centers, including training, communicating and guide to a high standard a broad level of clinical personnel in the actions and functions of the Neuro Exablate system.
* Participate in treatments of clinical brain indications, demonstrating expertise in all aspects of the technology.
* Review and analyze treatment results, development of updates for treatment techniques, and Quality Assurance methods.
* Support techno-clinical analyses using compliant technical data for quality support and outcomes enhancement.
* Participate in medical and scientific activities and derive publications or meeting summaries for external or internal presentation.
* Establish and review manuals and training materials, mainly but not limited, in Japanese.
* Work within a cross-functional regional pole with INSIGHTEC account, business and service employees to optimize the lifecycle of Exablate Centers.
* Travel domestically and internationally of at least 60% of the working time with short-time notification or amendment. May be required to work during the weekends and nights and may be required to engage in overnight travel.
* Work according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.
* Perform other related activities, as assigned.
 
Advantages:
* Educational or working experience abroad.
* Previous experience with focused ultrasound or MRI systems.
* Previous experience as a clinical application specialist or in a hospital.
* Familiarity with MR physics and imaging or focus ultrasound physics.
* Familiarity with human neuroanatomy, neurosurgery and/or movement disorders.