- 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 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.
- 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.
- 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.
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Medical Device Electrical Engineer - Florham Park, United States - Entegee
Description
Job Description
Job DescriptionSummary: Seeking an Electrical Engineer with a focus on medical devices to support manufacturing and R&D, ensuring compliance with regulatory standards.
Requirements:
Preferred Skills:
Responsibilities:
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.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.