Develops high-quality, reliable, and efficient hardware designs for medical devices, including analog, digital, and mixed-signal circuits. Collaborates with cross-functional teams to ensure successful integration of designs into medical products. Participates in the development of new products, from concept to production. Ensures successful integration of electrical design with mechanical and software elements of the system. Provides technical guidance and mentorship to junior engineers. Develops, modifies, and approves electrical design documentation, specifications, and drawings. Supervises/coordinates an engineer and/or technicians on assigned work. Defines design requirements and hardware specifications based on customer or user requirements. Contributes to the development and documentation of electronic system architectures. Conducts design reviews, trade-off analyses, and risk assessments to ensure the optimal design solution is selected for each project. Leads the creation of designs of electronic circuit schematics for microcontroller-based systems and microprocessor-based systems, meeting performance objectives. Analyzes circuits using calculation and simulation methods to assess performance limits, effects of environmental and load stress, and timing interfaces to ensure consistent performance in safety-critical applications. Stays up to date with industry trends, emerging technologies, and regulatory requirements to maintain a competitive edge. Contributes to the development of design verification and validation plans, as well as executing tests to ensure design compliance with specifications. Defines appropriate test methods to verify designs meet their performance requirements. Completes deliverables related to design of systems and sub-systems of the overall electrical architecture. Collaborate with suppliers and external partners to source components and ensure component reliability and availability. Participates in the transfer of design knowledge and intellectual property to manufacturing teams to ensure successful production ramp-up. Contributes to the continuous improvement of design processes, tools, and methodologies to improve efficiency and quality. Directs the layout of circuit assemblies to meet emissions and immunity performance requirements and design for manufacturability guidelines. Executes protocols and testing required to validate the safety and effectiveness of the design(s). Leads the troubleshooting and problem-solving efforts related to electrical aspects of devices and associated systems. Creates and communicates design/test plans, tasks, deliverables, and status. Manages time and resources to meet committed schedule milestones.) Qualifications A Bachelor's or Master's degree in Electrical or Electronics Engineering or a related field is required, with a minimum of 11 years of experience in electro-mechanical medical device product design, with knowledge of infusion pumps medical devices being an added advantage. A strong foundation in digital electronics, including logic design, digital circuits, and computer architecture. Proficiency in digital logic design, timing analysis, AC & DC analysis, and familiarity with simulation tools such as VHDL, Verilog, and Cadence is an added advantage. Strong knowledge of digital circuit design, digital system architecture, and design methodologies using microcontrollers, microprocessors, System on Module (SOM), CPLD, FPGAs, and ASICs. Knowledge of digital components, such as logic gates, flip-flops, memory technologies (such as SRAM, DRAM, and flash memory), digital signal processing, and communication protocols (such as I2C, SPI, USB, and Ethernet). Familiarity with Ethernet physical layers, such as RJ45, twisted pair, and fiber optics, and networking hardware, such as switches, routers, and hubs. Knowledge of Wi-Fi networking hardware, such as access points, routers, and client devices, and understanding of Wi-Fi network topologies, Wi-Fi testing and troubleshooting tools, and methodologies. Understanding of Wi-Fi power management and quality of service (QoS) mechanisms. Familiarity with Ethernet network management tools, such as SNMP and NetFlow, and Wi-Fi protocols, including TCP/IP, UDP, and ICMP. Understanding of Ethernet power over data (PoE) and power over Ethernet plus (PoE+) technologies. Knowledge of industry standards and regulations, such as TIA/EIA and ETSI, to ensure compliance with network performance and safety requirements. Familiarity with PCB layout and design for manufacturability (DFM) principles. Knowledge and experience using CAD systems for printed circuit board schematic design and layout (preferably Altium Designer). Understanding of signal integrity and power integrity concepts to ensure reliable performance of circuits. Experience with measurement and testing equipment to verify circuit performance. Experience with design automation tools, such as LabVIEW, Cadence Virtuoso, AWR Design Environment, or MATLAB. Strong problem-solving skills and the ability to work independently and collaboratively. Excellent communication skills, both written and verbal, with the ability to effectively communicate complex technical concepts to non-technical stakeholders. Strong organizational skills and the ability to manage multiple projects simultaneously. Experience with regulatory requirements, such as FDA 510(k) and IEC 60601, is a plus. Familiarity with agile development methodologies and the ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
