RESPONSIBILITIES:

Electrical Engineering
• Knowledge of electronic design and software design with strong 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 proficiency 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.