- Design and develop electronic assemblies using design control processes and procedures in accordance with the FDA design control guidelines established for type 2 and type 3 medical devices.
- Use technical principles, problem solving skills, and data analysis to support problem-solving for production and service departments.
- Develop and maintain technical documents such as design input requirements, test protocols, and reports.
- Lead initiatives to support manufacturing projects and goals such as part changes, product enhancements, and test fixture qualifications.
- Be a contributing resource for team project planning, prioritization, resource management and completion of deliverables on time.
- Adhere to all company policies, procedures, and business ethics codes.
- Duties may be modified or assigned at any time based on business need.
- Bachelor's degree in electrical engineering or related discipline.
- Minimum 3 years of experience in electronic engineering design and development; critical care medical devices preferred.
- 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
- Knowledge of FDA electronic design documentation and test requirements for 510k submissions.
- Knowledge of formal PCBA documentation (schematics, PCB fabrication drawings, PCB assembly drawings)
- Ability to perform root cause analysis and provide recommendations for non-conforming products.
- Strong technical writing and problem-solving skills.
- Excellent time-management skills, proactive and results driven.
- Able to work effectively both independently and in a collaborative team environment
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Electrical Design Engineer - Santa Ana, United States - Nihon Kohden Orange Med
Description
JOB PURPOSEThe Electronic Design Engineer is responsible for the electronic design and development for use in critical care medical device products.
ESSENTIAL FUNCTIONS AND MAIN DUTIES
QUALIFICATIONSEDUCATION / CERTIFICATION / EXPERIENCE REQUIRED:
COMPETENCIES REQUIRED:
WORKING CONDITIONSSCHEDULE:
The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required.
Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Company's discretion.
PHYSICAL:
Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 50 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision, and 2-way written/verbal communication in English.
More specific details may be provided as needed or requested.TRAVEL:
Occasional domestic travel may be required.
