Job Title: Electrical Engineer
Reports To:
FLSA Status: Exempt
Department: R&D


Summary: Designs and develops various electronic, electro-mechanical and electro-optical systems including digital and analog design, motor controls, sensors, and power management. This is a highly visible position as the principal EE in the company.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Design complex electronic circuits and systems to meet product specifications, including analog and digital electronics (FPGAs, CPLDs).
• Analyze, select and advise on electronic components and equipment. Participates in determining the design approach/electronic
architecture for complex systems.
• Ensures that designs are appropriately documented. Participates in or leads design reviews.
• Build relationships with PCB vendors, electronics distributors and vendors. May coordinate fabrication of first articles.
• Directly participate in board bring-up and test; may develop test procedures for incoming inspection or manufacturing.
• Integration of electronics into other aspects of products including software, mechanics and user interface.
• Pre-test systems for emissions and susceptibility (EMI/EMC); oversee or participate in third party testing. Supports safety testing
(IEC 60601/UL).
• Works cross-functionally with software, mechanical, and systems engineers. May lead development projects.
• Root cause analysis and trouble shooting techniques to help diagnose problems and implement solutions in the instrument areas as part
of NCR or CAPAs.
• Lead cross-functional teams with software, mechanical, and systems engineers to solve design and manufacturing issues.
• Performs any other duties assigned by management

Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

• Ten years of relevant electronic design experience, including integration of electronics into electro-mechanical systems. Experience
with complex systems (including motor control) preferred.
• Microprocessor system architecture and interfacing, including some C programming experience.
• Transistor and analog circuit theory.
• Digital device operation
• Control systems
• Printed circuit board schematic capture, layout and design incorporating S.M.T.
• Experience designing with CPLDs, FPGA, Verilog required.
• Experience working in an FDA QSR environment including:
     Documentation consistent with FDA expectations
     Risk Analysis techniques and mitigation development
     Design and evaluation to IEC 60601 safety and EMC standards
     Verification and validation activities
• Experience designing with some of the following:
     Sensors (optical, temperature, position, etc.)
     Stepper motors
     Temperature control in a product
     High performance electro-optical measurement techniques
• Experience transferring a product to manufacturing, including:
     Designing for testability
     Design verification testing
     Designing a test plan both at board assembly vendors and in-house
     Documentation of the design and the manufacturing process
• Experience providing support for operations including:
     Automation fixtures (PLC, image capture, custom circuits)
     Component end of life management
     Establish good working relationship with vendors
• Ability to collaborate cross-functionally across several departments and organizational levels.
• Ability to thoughtfully solve complex problems both independently and as part of a cross-functional team, including use of tools such as
DoE, SPICE simulation and mathematical analysis/tools.
• The Company reserves the right to require all employees to undertake additional or different job responsibilities when necessary to meet
business needs

Education/Experience:
BS in Electrical Engineering or Electronic Engineering

Managerial or team lead experience highly preferred

Experience in medical device or FDA-regulated industries

Supervisory Responsibilities:
This job may have supervisory/managerial responsibilities in the future.

Required Training:
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and EN13485 as well as the OptiScan Quality Manual and Quality Policy.

This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to
meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]