Senior Electrical Design Engineer

NIHON KOHDEN OrangeMed; Santa Ana (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

NIHON KOHDEN OrangeMed in Santa Ana is seeking a Senior Electrical Design Engineer to join the R&D electronic engineering team. The role involves the design and development of electronic systems for critical care medical devices, supporting both new and existing products.

The ideal candidate will have at least 5 years of electronic design experience, especially in critical care, and be skilled in FDA regulations and electronic CAD software. This position offers a competitive salary ranging from $120,000 to $150,000 annually.

Qualifications

• Minimum 5 years in electronic engineering design, preferably in critical care medical devices.
• Experience with ISO, IEC, FDA regulatory requirements for 510K submissions.
• Strong knowledge in verification and validation testing for high reliability devices.

Responsibilities

• Design and develop FDA-compliant electronic assemblies for medical devices.
• Contribute to project planning and resource management.
• Lead initiatives supporting manufacturing goals.

Skills

FDA electronic design documentation

Root cause analysis

Technical writing

Collaboration in team environment

Education

5+ years of electronic engineering design experience

Experience with electronic CAD software

FMEA design requirements knowledge

Job description

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.

Duties and 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.

Qualifications

Education and Experience

• 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.

Skills & Abilities

• 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.

Compensation

The anticipated range for this position is $120,000.00 to $150,000.00 at an annual base. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Working Conditions

• The Senior Electrical Design Engineer usually works in an office environment which includes laboratory and manufacturing areas.
• The Senior Electrical Design Engineer orks a standard work schedule and may need to extend hours as needed to meet company deliverables and deadlines.

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 30 lbs.