Senior Electrical Design Engineer

Nihon Kohden Orange Med; Santa Ana (CA); Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

A leading company in medical technology is seeking a Senior Electrical Design Engineer in Santa Ana, California. This role involves designing and developing electronic systems for critical care medical devices, adhering to FDA regulations. Candidates should have at least 5 years of design experience, familiarity with electronic CAD software, and the ability to work both independently and in a team. The position offers a competitive salary range from $120,000 to $150,000 annually, depending on qualifications and experience.

Qualifications

• Minimum of 5 years of electronic engineering design and development experience, critical care medical devices preferred.
• Experience with ISO, IEC, and FDA regulatory requirements for 510K submissions.
• Experience with verification and validation testing for high reliability critical care devices.

Responsabilités

• Design and develop electronic assemblies using FDA-compliant design control processes for medical devices.
• Contribute to project planning and ensure on-time completion of deliverables.
• Lead initiatives supporting manufacturing goals and maintain technical documentation.

Connaissances

FDA electronic design documentation knowledge

Root cause analysis

Excellent communication skills

Team collaboration

Outils

Electronic CAD software

Description du poste

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.