Electrical Engineer

Phase2 Technology; Florham Park (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Phase2 Technology in Florham Park, NJ seeks an Electrical Engineer with 3–5 years in engineering or manufacturing to support medical device hardware and software development. You will handle design, verification, regulatory documentation, and collaboration across R&D, manufacturing and QA teams.

Responsibilities include PCB layout, schematics, test plans, device verification, and ensuring compliance with IEC 60601 family standards and FDA documentation.

Qualifications

• BS in Electrical Engineering with 3–5 years in engineering or manufacturing.
• ISO-13485, MDD and CSA requirements understanding.
• Experience with analog/digital and real-time embedded electronics.
• Familiarity with PCB fabrication and layout tools.

Responsibilities

• Knowledge of electronic design and software design with regulatory documentation background.
• IEC 60601 and IEC 60601-2 standards knowledge.
• System-level verification and validation testing experience.
• Familiarity with FDA Design History Files, Device Master Records and MDD files.
• Strong technical writing and MS Word/Excel/Visio/PowerPoint skills.
• Collaborate with Repair/Manufacturing to improve product quality and reliability.
• Develop and maintain manuals, test procedures and BOMs.
• Create PC board layouts, schematics and assemblies.
• Develop test plans for hardware/software verification & validation.
• Perform hardware/software verification and validation testing.
• Develop process control techniques for manufacturing.
• Create assembly procedures and provide training/oversight.
• Support R&D subassembly design, PCB layouts and testing.
• Verify manufacturability and quality with R&D.
• Support safety testing processes.

Skills

Analog/Digital embedded

Real-time embedded electronics

High-speed digital design

Communication skills

Technical writing

Oscilloscopes

Logic Analyzers

Processor emulators/debuggers

C language

C#

Visual Basic

MS Office

Testing protocols

Prioritization

Autonomy

Team collaboration

Education

BS in Electrical Engineering

Tools

ORCAD

PADS

SPICE

Job description

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.