JOB DESCRIPTION
SENIOR ELECTRICAL ENGINEER for a revolutionary Surgical Device.
Kogent Surgical is developing a revolutionary powered ultrasonic system for COMPLETE removal of brain and spine tumors, and delicate cutting of bone. We are a rapidly growing medical device company seeking a Senior Electrical Engineer to join a surgical power tool development team. Our experienced team has over 40 years of experience in the design, manufacturing, and quality control of neuro-surgical products. We require this position to be very hands-on and the right candidate should have the ability to collaborate with internal and external design and manufacturing partners.
RESPONSIBILITIES:
Designing circuit board level test equipment for engineering and manufacturing use
Coordinating with circuit board and component suppliers
Performing system requirements verification testing
Resolving product integration issues and production anomalies
Work closely with cross-functional teammates to design and problem solve (software engineering, mechanical engineering, packaging engineering, quality engineering, regulatory, clinical engineering)
Responsible for design controls, including documenting design/developing planning, design input, output, review, transfer, changes, and design history file
Assist with the first-time setup and provide on-going support for new production systems and processes; Assist in troubleshooting manufacturing processes as needed
Growing knowledge of medical device development including FDA quality system regulation, international regulation, safety agencies, quality system and industry standard practices
Identify and select parts and materials needed for production; coordinate with external suppliers and manufacturers as well as with purchasing department
Start and finish projects in accordance with a timeline and a budget
QUALIFICATIONS:
A Bachelor’s or Master’s Degree in Electrical Engineering or related field
2+ years relevant experience
Proficiency with OrCAD or other circuit design tools
Ability in technical writing & ALL office software that pertains to the position
Experience in a medical device research and development environment is preferred
Working knowledge of the electrical design process
Ability to interpret and analyze system drawings with basic Mechanical/Software/Electrical Interactions
Familiarity with FPGA design, VHDL
Familiarity with IEC60601-1, IEC60601-1-2, IEC61000-4-6 or equivalent, for complex medical systems is a plus
BENEFITS: