Electronic Design Engineer
The Electrical Design Engineer will be involved in all aspects of the product development life cycle: concept development and feasibility assessment, electronic architecture and design, schematic capture and layout, bread boarding, V&V testing and manufacturing transfer. This position will interface with potential and existing customers to understand product requirements, assist in proposal generation and ensure customer requirements are satisfied through the design process.
Previous experience in electrical design and testing for Class II and III medical devices under an ISO 13485 quality system is expected. Broad electrical experience in digital microprocessor design, wireless technologies such as Bluetooth or MICS, power management circuits, sensors, and data acquisition and processing is required. Experience in development and integration of firmware is strongly desired.
Key responsibilities will include, but are not limited to:
- Work with customers, sales and other engineers to define customer product and development requirements
- Assist in generation of proposals for feasibility, development, V&V and manufacturing transfer projects
- Develop system architecture and detailed electrical design to customer’s specifications
- Evaluate and select components and suppliers
- Develop electronic design files: schematic design and capture, PCB layout, BOMs and components specifications (Altium preferred)
- Support and manage PCB layout, prototyping and troubleshooting activities
- Support firmware development and integration
- Prepare test plans, and conduct or support Verification and Validation testing
- Experience testing to IEC 60601, FCC and ETSI standards
- Strong understanding of ISO 13485 and FDA quality processes for Class II & III devices
- Develop the necessary product documentation including Design History Files, Device Master Records, DFMEA and PFMEA
- Collaborate effectively with other engineers, sales, quality, purchasing, mechanical, firmware, system test, and manufacturing departments to assist in manufacturing transfer efforts
The Engineering Design Department drives new products technologies for medical devices, aerospace, telecommunications, and IoT
Experience and Skills
Bachelor or Master’s Degree in Electrical Engineering with five or more years of relevant work experience with digital circuit design, basic signal integrity, PCB layout (Altium), prototyping and testing. Experience developing hardware circuitry design, PCB layout, selection of electronic components, packaging, and box build to customer’s Statement of Work specification. Previous experience under ISO 13485and FDA design controls required along with experience designing and testing to IEC 60601-1 and IEC 60601-1-2 standards.
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