Medical Device Electrical Engineer - Entegee

Summary: Seeking an Electrical Engineer with a focus on medical devices to support manufacturing and R&D, ensuring compliance with regulatory standards.

Requirements:

• BS in Electrical or Electronic Engineering with 3-5 years of relevant experience.

• Proficiency in electronic and software design within medical device regulatory documentation.

• Understanding of IEC 60601 and IEC 60601-2 standards.

• Experience in system-level verification and validation testing.

• Familiarity with FDA Design History Files, Device Master Records, and MDD technical files.

• Strong capability in technical documentation writing with proficiency in MS Word and Excel.

Preferred Skills:

• Expertise in analog/digital electronics for microprocessor-based, FPGA/CPLD, and DSP hardware platforms.

• Proficient with schematic diagram development tools (ORCAD/PADS), PC board layout tools (ORCAD/PADS), and simulation tools (SPICE).

• Knowledge of board layout concepts, EMC, ESD, precision low current measurement, and low noise analog electronics.

• Experience with Microsoft Visual Studio Visual Basic or C#, the C language, software testing protocols.

• Skilled at using oscilloscopes, Logic Analyzers, processor emulators/debuggers.

Responsibilities:

• Collaborate with Repair Technicians to streamline troubleshooting & repair processes; recommend design improvements for product quality and reliability.

• Build & test prototypes; troubleshoot electrical issues to identify root causes; implement solutions.

• Develop manuals, test procedures, BOMs; oversee assembly procedures implementation and provide training.

• Create test plans for hardware/software verification; conduct validation testing.

• Implement process control techniques for manufacturing processes.

• Support R&D group in subassembly design, PC board layout, testing; ensure manufacturability of new products.

 

 

 

 

Pay Details: $90,000.00 to $95,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.