חברות הייטק בישראלSpectrum Dynamics MedicalLead System Engineer, R&D

Lead System Engineer, R&D

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Spectrum Dynamics Medical· Medical Equipment Manufacturing
Caesareaפורסמה החודש

כישורים מהמשרה

System architecture and integration for electromechanical devicesSystem-level requirements management and traceabilityDesign controls and regulatory compliance documentationRisk analysis (ISO 14971) and usability engineeringIntegration of multidisciplinary components (hardware/software/firmware)Trade-off studies and interface issue resolutionVerification & Validation (V&V) planning and test executionTechnical risk mitigation and technical decision-makingKnowledge of ISO 13485 and ISO 14971Excellent technical writing in English for regulatory documentation

תיאור המשרה

Lead System Engineer, R&D - spectrum-dynamics Skip to content CAREERS Think you are qualified for this position Send CV: [email protected] Israel Lead System Engineer, R&D Caesarea Spectrum Dynamics Medical is engaged in the development, manufacturing, sale and service of state-of-the-art nuclear medicine imaging systems. We are spearheading the transformation of the Single Photon Emission Computed Tomography imaging systems from analog to digital detection technology, enabling hospitals and clinicians to provide superior healthcare services at much lower cost. We launched the world first digital cardiac dedicated SPECT system – the D-SPECT® Cardio system – in 2007. Since then, the D-SPECT® has become the system of choice for functional cardiac imaging hundreds of systems sold worldwide. The D-SPECT® employs digital detectors made of Cadmium Zinc Telluride (“CZT”), which along with ingenious hardware design, proprietary software and proprietary algorithms, enables imaging of cardiac patients at unprecedented speed, at a low radiation dose, and with superior image quality. The D-SPECT® is a platform for next generation imaging, and therapy guiding cardiac applications. Recently we launched its multipurpose SPECT and SPECT-CT systems – the Veriton® and the Veriton-CT® – the Veriton® systems employ digital CZT detectors mounted on 12 robotic arms arranged at 360° around the patient. They are integrated with innovative hardware and software design that enables users to image multiple organs (brain, thyroid, cardiac, lungs, bones etc.) at high speed, low radiation dose, and with significant improvement in image quality. The Veriton-CT® system includes a high speed, low dose, 16 or 64 slice CT, which is upgradable to 128 slices. The Veriton-CT® provides best in class combined functional and anatomic images. Position Overview The leading system engineer is responsible for designing, testing and improving technology solutions as per the client’s product requirements and safety implications. work collaboratively with engineers, designers, and product managers to define system requirements, drive product development, and ensure solutions meet customer expectations and business goals. The Lead System Engineer reports to VP R&D, works closely with the product managers to develop product roadmaps and timelines. Position Responsibilities • System Architecture & Design: Creating and maintaining the overall system architecture, design, and integration strategies for complex electromechanical devices. • Requirements Management: Defining, documenting, and managing system-level requirements, ensuring traceability from user needs and RMF (Risk Analysis) to design outputs. • Design Control & Compliance: Developing documentation required for regulatory compliance (based on FDA/ISO/CE), including design history files, risk analysis, and usability engineering. • Integration & Technical Leadership: Leading the integration of multidisciplinary components (hardware, software, firmware), conducting trade-off studies, and solving interface issues. Provide technical support to customers and other team members as needed. Stay updated with industry trends and implement changes in the systems accordingly. • Verification & Validation (V&V): Developing, reviewing, and executing system verification and validation plans and test cases to ensure the product meets safety and performance standards. • Technical Strategy & Risk Mitigation: Identifying technical risks early, defining system-level budgets (power, performance), and driving technical decision-making. Experiences, Knowledge, Skills, and Abilities • Education: BSc or MSc in Systems, Electrical, Mechanical, SW, Physics or Biomedical Engineering. • Experience: 5+ years in medical device development, with experience in system integration, design controls, and technical leadership. • Domain Expertise: Strong knowledge of ISO 13485, ISO 14971 and other standards concerning development of medical devices and regulations, plus familiarity with multidisciplinary systems. • Skills: Strong communication, cross-functional collaboration, and the ability to work in a global team environment. Familiarity with project management tools and techniques. Excellent technical writing skills in English for regulatory and design documentation Share this position: Follow Spectrum: Facebook Linkedin Esha Bandyopadhyay General Counsel and Corporate Secretary Board Esha Bandyopadhyay serves as Spectrum Dynamics Medical’s General Counsel and Corporate Secretary of the Board. In this role, she leads all of the company’s legal and compliance functions. She brings to Spectrum a quarter century of legal experience with a particular focus on the medical device industry. Prior to joining Spectrum, Esha was a partner at several distinguished law firms, including Fish & Richardson, Winston & Strawn, and Kirkland & Ellis. Esha holds a JD from U.C. Berkeley School of Law, and a BA in Economics from the University of California, San Diego, where – at 18 – she was the youngest graduate in the university’s history. Xin Ma Head of China Operations Xin serves as Shanghai Guangmai (SD ’ s China Division) CEO since 2021. Before joining the company, Xin served as CEO at Foze Medical Technology Limited and CEO at Shanghai Hi-tech Medical Technology limited for over 12 years. Xin graduated from Kellogg School of management with MBA degree and from London School of Economics with MSc in Information Technology. This website uses cookies to ensure you get the best experience on our website. accept Shlomi Aloya VP of Customer Support Shlomi Aloya is responsible for leading the global customer support organization of Spectrum Dynamics Medical. Shlomi has a vast service, operation and R&D experience of over 22 years in leading technical teams for capital equipment companies. Shlomi holds BA Executives degree Business Administration and a M.A. Decision making & Negotiation Ruthie Ben-kish VP of Research & Development and Program Management Officer Ruthie Ben – Kish serves as the director of software development an d manages the main products development programs in Spectrum Dynamics Medical . Ruthie joined the company as s oft ware d epartment m anager and was then promoted to D irector of Software development before assuming her current role. Ruthie brings to S pectrum D ynamics Medical over 25 years of experience in development of medical imaging and diagnostic systems of multiple modalities. Ruthie holds a BSc degree in Electrical Engineering and a MSc degree in Biomedical Engineering from the Technion I nstitute of Technology . Dalia Shiti VP of Clinical Applications Dalia Shiti serves as Spectrum Dynamics Medical Vice President of clinical applications being responsible for the a pplications training of the company’s customers worldwide. In her previous role s in the company Dalia served as clinical application s specialist and clinical application manager . Before joining the company Dalia served as leading technician in Bnai Zion Medical Center, Israel. Nilda Rivera Senior Director of Product Marketing Nilda Rivera is responsible for the worldwide marketing activities of Spectrum Dynamics Medical including trade shows, advertisement, web and social media, product s definition, sales tool development etc. Prior to joining the company Nilda worked at GE for many years and held various senior nuclear medicine and PET sales and marketing roles . Before joining GE Nilda worked as s taff n uclear m edicine t echnologist / c linical i nstructor University of Miami Jackson Memorial Hospital . Nilda holds a B Sc degree in B iology/ C hemistry from the University of Miami and is also nuclear medicine technologist. Ayelet Dekel VP of Human Resources Ayelet Dekel serves as Spectrum Dynamics Medical Vice President of hu man resources , being responsible for the global people operations . Ayelet joined the company as s upply chain manager later becoming VP of Operations and HR manager before assuming her current role in the company. Ayelet brings to Spectrum Dynamics 20 years of experience in the global operations and human resources management . Ayelet holds a BSc degree in i ndustrial engineering and an Advanced Certificate Studies in Human Resource s from Bar Ilan University. Get full access to all exclusive content Complete the form below and verify your email address to unlock the content. I want to subscribe to newsletter Send Get full access to all exclusive content Complete the form below and verify your email address to unlock the content. I want to subscribe to newsletter Send Get full access to all exclusive content Complete the form below and verify your email address to unlock the content. I want to subscribe to newsletter Send which product would you like to demo Currently a Spectrum Dynamics User? Yes no If not a Spectrum Dynamics user, please indicate GE Healthcare Siemens Healthineers Philips Other Purchasing Plans: 0-6 months Over 6 months Seeking Information Subscribe to Spectrum Dynamics Digital SPECT News. Receive via email updates and information about our solutions and events. Create a Username & Password Register Please fill out this form to access our webinars Complete the form below and verify your email address to nlock the content. Register Get full access to all exclusive content Complete the form below and verify your email address to unlock the content. I want to subscribe to newsletter Send Igor Naroditsky VP of RA & QA Igor Naroditsky is responsible for the Regulatory Affairs and Quality Assurance of Spec trum Dynamics Medical. Igor brings over 20 years of solid quality, regulatory and engineering experience in the healthcare and capital equipment industry . Prior to joining Spectrum Dynamics, Igor served as Vice President of Quality and Regulatory at KarmelSonix (ASX: KSI), an Australian healthcare company. Before that, he served for 10 years as Director of Global Quality Assurance and Regulatory Affairs at Camtek (NYSE: CAMT). Igor holds a B Sc degree in Industrial Engineering from Ben Gurion University and a MSc degree in System Engineering and Management from the Technion Institute of Technology and is a Certified Quality Engineer. Amir Stadtmauer VP of Operations Amir Stadtmauer is responsible for leading the global operations activi ties of Spectrum Dynamics Medical , which includes m anufacturing, s ourcing , l ogistics , i nformation s ystem and e ngineering . Amir has a vast s upply c hain experience of over 22 years in leading operation teams of capital equipment companies . Amir holds an MSc degree in Industrial Engineering and Management from Tel-Aviv University. Tomer Gabay Chief Executive Officer Tomer Gabay serves as Spectrum Dynamics Medical’s CEO, being responsible for setting the company’s vision and strategy, leading the executive team and other senior management, balancing short-term and long-term goals, and driving growth by exploring new business models, markets, and products. Before assuming the role of CEO, Tomer served as the company’s CFO. Before joining the company, Tomer served as an audit manager of public and private companies in various industries at PwC Israel. Tomer brings over 15 years of experience holding leadership roles in finance, business and operations in global organizations, as well as startups, including business planning, budgeting, forecasting, negotiations, due-diligence and fundraising. Tomer holds a BA in Economics and Accounting, and is a certified public accountant. Nathaniel Roth Chief R&D and Clinical Research Officer Nathaniel Roth serves as Spectrum Dynamics Medical Vice President of research and development where he oversee s and leads the development of the company’s products , clinical research and innovative technologies . Nath aniel joined the company as physicist later taking roles of Chief Physicist, Chief Physicist and Clinical Research Director, R&D manager before assuming his current role . Prior to joining the com
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High-definition Functional Nuclear Imaging

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