RESPONSIBILITIES:
Electrical Engineering
- * Knowledge of electronic design and software design with s
- * trong background in medical device regulatory documentation
- * Extensive knowledge of IEC 60601 and IEC 60601-2 standards
- * Experience in verification and validation testing at system level
- * Knowledge of FDA Design History Files, Device Master Records and MDD technical files
- * Strong technical and documentation writing skills,
- Strong word and excel competency
Manufacturing Engineering Support
- * Work with Repair Technicians to ensure troubleshooting & repair is effective & efficient. Recommend design changes to improve product quality, performance, cost, & reliability.
- * Build & test prototypes for new product development. Trouble-shoot difficult electrical problems, determine root cause, and implement solutions.
- * Develop and maintain manuals, test procedures and BOMs. Develop PC board layout, electrical schematics, and complete assemblies.
- * Develop test plans for hardware/software verification and validation. Perform hardware/software verification and validation testing.
- * Develop and implement process control techniques and procedures for manufacturing.
- * Create assembly procedures and work instructions for all phases assembly and provide training and oversight to carry through implementation.
R&D Group Support
- * Support R&D group with their subassembly design, PC board layout, electrical schematics, and testing. Assist in the development of manuals, test procedures and BOMs by R&D group.
- * Verify the manufacturability and quality of new products. Interface with R&D engineering group regarding resolution of technical problems identified with design or software.
Regulatory Support
- Support safety testing process
QUALIFICATIONS:
Capability of performing all aspects of systems engineering, including concept, architecture, block/functional diagrams, system level documentation.
- * Knowledge of design, debugging and support of analog/digital, plus real-time embedded electronics for both microprocessor-based, FPGA/CPLD and DSP hardware platforms.
- * Understand the printed circuit board fabrication process with proficiency in using schematic diagram development tools (ORCAD/PADS), PC board layout tools (ORCAD/PADS), and simulation tools (SPICE).
- * Knowledge with board layout concepts, especially EMC and ESD.
- * Extensive experience in precision, low current measurement, and low noise analog electronics.
- * Knowledge in Microsoft Visual Studio Visual Basic or C#. the C language, software testing protocols, and p roficiency with MS Office (Word, Excel, Visio, PowerPoint and Outlook).
- * Strong communication skills and good technical writing skills. Detail oriented with solid organizational skills.
- * Skilled at using oscilloscopes, Logic Analyzers, and processor emulators/debuggers. Good software testing skills.
- * Ability to prioritize effectively and work on concurrent project, proactively and constructively make suggestions for process or product improvement.
- * Ability to work both autonomously and in a collaborative team environment.
EDUCATION:
BS in Electrical or Electronic Engineering with 3-5 years' experience working in an engineering or manufacturing environment. Strong understanding of ISO-13485, MDD and CSA requirements for engineering. Understanding of Safety and EMC standards.