דרושים » רפואה ופארמה » Regulatory Compliance & Certification Manager

our companys Product Engineering group is looking for a highly motivated Hardware Engineer to lead Change Impact Analysis activities related to engineering design changes (ECOs/ECRs) across our cutting-edge networking and computing platforms. This role is critical to ensuring that all product modifications are seamlessly evaluated for their impact on hardware, mechanical design, system performance, and test coverage across the product lifecycle. You will work closely with R&D, mechanical engineering, manufacturing, quality, and test teams to assess risks, define mitigations, and maintain excellence in product integrity and testability.
What Youll Be Doing:
Leading engineering change analysis (ECO/ECR) processes across complex hardware systems.
Evaluating the impact of component, layout, and mechanical changes on hardware functionality, manufacturability, and testability.
Collaborating with cross-functional teams to ensure smooth implementation of changes without compromising product quality.
Supporting DFT (Design for Testability) requirements in the face of ongoing design changes.
Reviewing BOM and layout revisions and assessing ripple effects on power delivery, signal integrity, and thermal performance.
Maintaining change traceability and documentation to meet engineering and compliance standards.
Coordinating with manufacturing and operations teams to ensure product readiness and alignment with production timelines.

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.

we are leading the way in groundbreaking developments in Artificial Intelligence, High-Performance Computing and Visualization. The GPU, our invention, serves as the visual cortex of modern computers and is at the heart of our products and services. Our work opens up new universes to explore, enables outstanding creativity and discovery, and powers what were once science fiction inventions from artificial intelligence to autonomous cars. we are looking for excellent people like you to help us accelerate the next wave of artificial intelligence.
We are looking for a skilled, creative, and highly motivated Senior PHY System Engineer to join the End-to-End (E2E) physical-layer performance team, as part of the Post-silicon department
What youll be doing:
End-to-End responsibility on the link level performance characterization, verification, and debugging.
Debugging of link issues of our company's systems, while diving into the product HW design and SW/FW operation.
Characterizing optical and electrical performance using lab equipment and SW tools.
Take an active part in silicon bring-up while managing E2E testing of newest ASICs, with the objective of driving product to mass production with first-in-class performance.
Characterizing products performance using lab equipment, such as oscilloscope, Spectrum/Network analyzer, Pattern-generator, etc.
Working in front of various test teams, with the responsibility of addressing issues and monitoring the test flows conducted by them
Leading data-driven discussions about the product functionality and areas for improvement.
Testing our company's Electro-Optical and Electrical chips and systems.
Defining testing requirements for new products based on electrical and optical specifications.

We are looking for a creative and independent software engineer for tester infrastructure tools and workflows development for the IC test and product engineering group in our company Networking Business Unit. our company Networking Business Unit has continuously reinvented itself over two decades. Our high-speed buses & network products are leading in the markets with innovative ways to improve speed and bandwidth from one generation to another and today we are known as the go-to place for End-to-End High-Speed Ethernet and InfiniBand Solutions.
As our company is rapidly growing, it faces new and exciting challenges that requires us to build our teams with smart people who can join us at the cutting-edge technology. We need a creative individual, who will help move Network Silicon ICs products (Switch, NIC, SmartNic) from design to mass production. You will work with test engineers, test house, Design, IT and many other professionals in the organization for the Tester infrastructure development tools and flows for speeding time to market and enabling next generation test capabilities. If you are passionate about enabling of the highest quality Network products in the market, we want to hear from you!
What you'll be doing:
Build workflows and tools to allow fast migration from the Silicon design phase to the testing phase
Design, develop, and maintain mission-critical engineering applications and automation tools.
Architect and implement infrastructure for scalable debug workflows targeting next-generation network silicon.
Collaborate with cross-functional teams to enhance HW/SW automation flows and characterization pipelines.
Closely work with External vendors on enabling new features and enhancements to improve work efficiency
Leverage DevOps best practices (CI/CD, version control, infrastructure automation) to accelerate internal development cycles.

Widely considered to be one of the technology worlds most desirable employers, we are an industry leader with groundbreaking developments in High-Performance Computing, Artificial Intelligence and Visualization. The GPU, our invention, serves as the visual cortex of modern computers and is at the heart of our products and services. Our work opens-up new universes to explore, enables amazing creativity and discovery and powers what were once science fiction inventions from artificial intelligence to autonomous cars.
The Senior Power Design Engineer will be responsible to design our companys datacenter products such as Switches, Adaptors and electro-optical cables. In this role you will be responsible for all aspects of product from definition, design to execution. Continuously renewing your academic foundation, validated by active exposure of industry experience. Interact closely with company experts and become an integral member of a global collaborative team. Join us and be a part of this fast paced, dynamic environment !
What you will be doing:
Design datacenter system power solutions, such as switches, adapters and electro-optical cables.
Perform validation of system power solutions.
Design power solution test platforms.
Collaborate, provide feasibility analysis, present options and review of ODM power solutions.
Execute system power bring-up and debugs.
Define system power testing specifications.
Engage with vendors to resolve system power issues.

we're a global leader in smart energy technology, with over 3,000 employees, offices in 34 countries, and millions of installations worldwide. Our innovative solutions include solar inverters, battery Storage, backup systems, EV charging, and AI-based energy management. We're committed to making clean, green energy the primary power source for homes, businesses, and beyond. With the growing demand for electricity, the need for smart, clean energy sources is constantly rising. SolarEdge offers amazing opportunities to develop your skills in a multidisciplinary environment, covering everything from research and development to production and customer supply. Work with talented colleagues, tackle exciting challenges, and help create a sustainable future in an industry that's always evolving and innovating. Join us and be part of a company that values creativity, agility, and impactful work. We invite you to join our manufacturing in north Israel. By being SolarEdges Quality Engineer you will have the opportunity to build a full proof quality system to establish the high quality and reliability products that assure the expected long-life warranty of the products. What will you be doing?
*  Define and Implement methods and reporting systems to monitor the quality in all factory related processes.
* Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
* Analyze data and lead over all cross-organization improvements plan
* Lead Failure Analysis investigations and implement cross organization Corrective and Preventive actions
* Represent production quality related issues

our company has been transforming computer graphics, PC gaming, and accelerated computing for more than 25 years. Its a unique legacy of innovation thats fueled by great technologyand amazing people. Today, were tapping into the unlimited potential of AI to define the next era of computing. An era in which our GPU acts as the brains of computers, robots, and self-driving cars that can understand the world. Doing whats never been done before takes vision, innovation, and the worlds best talent. As a worker, youll be immersed in a diverse, supportive environment where everyone is inspired to do their best work. Come join the team and see how you can make a lasting impact on the world. we are looking for a HW Board Design Engineer to join the System Product Engineering HW Jig team to lead the design and execution of test board projects for systems products.
What you will be doing:
Lead board design through all development stages: from definition to implementation, bring-up, qualification and finally release.
Full responsibility for electrical specification, schematic design, components selection and layout considerations.
Extensive lab bring-up and debugging until the testing platform efficiently implemented in the Production floor.
Combine understanding of the electronics, FW and SW aspects into the accurate system architecture.
Collaborate with multiple R&D and Production groups: Mechanics, Signal Integrity, Layout, Software and Testing (JTAG and FT).

our company Networking business unit is looking for Lab practical engineer for IC product engineering group, who will work in our company R&D labs in Yokneam. As an IC test practical engineer candidate will be performing various types of testing of our company/Mellanox ICs on ATE, evaluation boards and reliability platforms, as part of design and production validation, IC characterization and reliability activities. This job allows you to work in a complex, exciting engineering environment handling challenging IC testing activities.
What youll be doing:
One responsibility of this position will be handling various types of testing of our company ICs.
Perform IC testing in order to produce reliable and precise data to support IC devices analysis.
Maintaining and operating laboratory equipment such as IC evaluation systems, HTOL system, Scopes, DVMs and another tooling.
Reading Schematics of electronic circuits.
Support all related activities such as IQC, OQC, IC Inventory managing and shipments.
Carrying out Q&R tasks and following strict execution methodologies.
Following and ensuring strict safety procedures and safety checks.

our company Networking business unit is looking for Lab practical engineer for IC product engineering group, who will work in our company R&D labs in Yokneam. As an IC test practical engineer candidate will be performing various types of testing of our company /Mellanox ICs on ATE, evaluation boards and reliability platforms, as part of design and production validation, IC characterization and reliability activities. This job allows you to work in a complex, exciting engineering environment handling challenging IC testing activities.
What youll be doing:
One responsibility of this position will be handling various types of testing of our company ICs.
Perform IC testing in order to produce reliable and precise data to support IC devices analysis.
Maintaining and operating laboratory equipment such as IC evaluation systems, HTOL system, Scopes, DVMs and another tooling.
Reading Schematics of electronic circuits.
Support all related activities such as IQC, OQC, IC Inventory managing and shipments.
Carrying out Q&R tasks and following strict execution methodologies.
Following and ensuring strict safety procedures and safety checks.