Entegee · 14 hours ago
Senior Electrical Engineer – Medical Devices
Costa Mesa, CA
Full-time
Onsite
Senior Level
$110K/yr - $160K/yr
6+ years expEntegee Engineering is seeking an experienced Electrical Engineer with a strong medical device background. The role involves leading investigations into complex electrical and electromechanical issues in released medical devices and ensuring compliance with regulatory requirements.
Information TechnologyStaffing Agency
Hiring Manager
Ryan Taylor
Responsibilities
Lead investigations into complex electrical and electromechanical issues in released medical devices
Troubleshoot and resolve system-level complaints using structured root cause analysis
Diagnose failures related to sensors, motor drivers, power electronics, and control systems
Design and modify electrical circuits, subsystems, and PCB assemblies of moderate to high complexity
Create and review schematics, PCB layout guidance, BOMs, and build packages
Support system integration, verification, validation, and troubleshooting, including safety, EMC, and reliability testing
Develop and execute verification and validation (V&V) test plans aligned with product and regulatory requirements
Apply advanced problem-solving methodologies such as RCA and FMEA to implement corrective and preventive actions
Partner with manufacturing and suppliers to ensure design for manufacturability and testability
Ensure all design activities and documentation comply with FDA QSR, ISO 13485, IEC 60601, and internal QMS requirements
Qualification
Required
Experienced Electrical Engineer with a strong medical device background
Familiarity with IEC 60601-1 testing and compliance
Lead investigations into complex electrical and electromechanical issues in released medical devices
Troubleshoot and resolve system-level complaints using structured root cause analysis
Diagnose failures related to sensors, motor drivers, power electronics, and control systems
Design and modify electrical circuits, subsystems, and PCB assemblies of moderate to high complexity
Create and review schematics, PCB layout guidance, BOMs, and build packages
Support system integration, verification, validation, and troubleshooting, including safety, EMC, and reliability testing
Develop and execute verification and validation (V&V) test plans aligned with product and regulatory requirements
Apply advanced problem-solving methodologies such as RCA and FMEA to implement corrective and preventive actions
Partner with manufacturing and suppliers to ensure design for manufacturability and testability
Ensure all design activities and documentation comply with FDA QSR, ISO 13485, IEC 60601, and internal QMS requirements
Medical device electrical engineering experience
PCB design and system-level electrical design control
Troubleshooting and resolving sensor-level issues in regulated products
Experience supporting released products through complaints, CAPAs, and field issues
Bachelor's degree in Electrical Engineering or related discipline
6+ years of relevant experience
Working knowledge of FDA QSR, ISO 13485, IEC 60601, ISO 14971
Preferred
Experience with electrical safety and EMC testing strongly preferred
Benefits
Medical
Dental
Vision
Term life insurance
Short-term disability insurance
Additional voluntary benefits
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay
Company
Entegee
Entegee is a staffing and recruiting company providing contract engineers and technical specialists.
201-500 employees
H1B Sponsorship
Entegee has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (1)
2022 (4)
2021 (8)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Bob Bolster
Chief Operating Officer
Company data provided by crunchbase