Senior Electrical Design Engineer

Orange Med; Santa Ana (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

A healthcare technology company in California is seeking a Senior Electrical Design Engineer to join the R&D team. This role involves the design and development of electronic systems for critical care medical devices. Key responsibilities include leading projects, ensuring FDA compliance, and maintaining technical documentation. The ideal candidate has over 5 years of engineering experience, particularly with critical devices, and strong expertise in electronic CAD software. This position offers a competitive annual salary ranging from $120,000 to $150,000.

Qualifications

• 5+ years in electronic engineering design, preferably in critical care devices.
• Proficient in electronic CAD for design processes.
• Understanding of FDA, ISO, IEC regulations for medical devices.

Responsibilities

• Design and develop electronic assemblies for medical devices following FDA compliance.
• Contribute to project planning and manage resources to meet deadlines.
• Develop and maintain necessary technical documentation.

Skills

FDA electronic design documentation

Root cause analysis

Technical writing

Collaboration

Tools

Electronic CAD software

Job description

Career Opportunities with Nihon Kohden Orange Med

A great place to work.

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

• 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 to $150,000 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 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 30 lbs.