Lead System Engineer, R&D

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. System Engineers work closely with other engineers, designers and product managers to ensure that products meet customer’s needs and goals.

The Lead System Engineer reports to VP R&D.

The Lead System Engineer works closely with the product managers to develop product roadmaps and timelines.

Position Responsibilities and Deliverables

• 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.

Required qualifications & Skills

• 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.