Senior Electrical Design Engineer

Nihon Kohden Orange Med • Santa Ana, CA

6d • $120,000 - $150,000

About The Position

The Senior Electrical Design Engineer is an integral member of the R&D electronic engineering team, responsible for the design and development of electronic systems for critical care medical devices. This role supports electronic development for both new and existing products, ranging from simple to complex systems including PCB design, system wiring, and electro-mechanical integration.

Requirements

• Minimum of 5 years of electronic engineering design and development experience. Critical care medical devices preferred.
• Minimum of 5 years of design experiencing using electronic CAD software packages.
• Experience with ISO, IEC, and FDA regulatory requirements for 510K submissions related to high reliability critical care medical devices.
• 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.
• Strong knowledge of FDA electronic design documentation and test requirements for 510k submissions.
• Ability to perform root cause analysis and provide recommendations for non-conforming products.
• Excellent listening, proficient in both verbal and written communication, and technical writing skills.
• Able to work effectively both independently and in a collaborative team environment.
• 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 30 lbs.

Responsibilities

• Design and develop electronic assemblies using FDA-compliant design control processes and procedures for Class II and Class III medical devices.
• Contribute to project planning, prioritization, resource management, and on-time completion of deliverables.
• Apply technical principles, problem-solving skills, and data analysis to support production and service departments.
• Lead initiatives that support manufacturing goals, including part changes, product enhancements, and test fixture qualifications.
• Develop and maintain technical documentation such as design input requirements, test protocols, and reports.
• Adhere to all company policies, procedures, and business ethics standards.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed