Published Description
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.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records.
#GRP2
Job Type: Full-time
Pay: $90,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
Experience:
- Electrical engineering: 1 year (Required)
- Medical Device: 1 year (Required)
- ISO 13485: 1 year (Required)
- system-level verification and validation testing.: 1 year (Required)
- IEC 60601 and IEC 60601-2 standards: 1 year (Required)
Ability to Relocate:
- Florham Park, NJ: Relocate before starting work (Required)
Work Location: In person