Sr. Electrical Design Engineer - Nihon Kohden Orange Med

Job Purpose

The Senior Electrical Engineer is an integral member of the electrical team within the R&D department. This position supports electronic design and development for new and existing products ranging from simple to complex electronic systems such as PCB board, system wiring, and electro-mechanical development.

Essential Functions and Basic Duties

• Develop complex electronic designs and maintain existing products using design control processes and procedures in accordance with the FDA design control guidelines established for type 2 and type 3 medical devices.
• Be a contributing resource for team project planning, prioritization, resource management and completion of deliverables.
• Lead initiatives and collaborates with cross-functional team members to support tasks such as part changes, product enhancements, and test fixture qualifications.
• Develop and maintain technical documents such as design input requirements, test protocols, and reports.
• Provide technical guidance and act as a mentor to team members as needed.
• Other duties as assigned.
• Adheres to all company policies, procedures, and business ethics codes.

Qualifications
• A bachelor's degree in electrical engineering, master’s degree preferred.
• Minimum 5 years of electronic engineering design and development experience. Critical care medical devices preferred.
• Minimum of 5 years of design experience using electronic CAD software packages.
• Experience with the development and performance of verification and validation testing required for high reliability critical care devices.
• Experience in FMEA design requirements for critical care devices.
• Capable of analyzing and solving complex problems and making decisions based on data analysis.
• Experience working with suppliers of electronic components, subassemblies and finished devices.
• Ability to perform root cause analysis and recommendations for non-conforming products.
• Excellent listening, verbal communication, and technical writing skills.
Preferred Qualifications
• Electronic design experience of IPC class 3 critical devices.
• Experience with ISO, IEC, and FDA regulatory requirements for 510K submissions related to high reliability critical care medical devices.

Working conditions

• Works in an office environment which includes laboratory and manufacturing areas. Occasional domestic travel may be required.
• Works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.

Physical Requirements

• Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs.