Hardware Verification/test Engineer

Senior Hardware Verification/test Engineer

Job location : Santa Rosa, CA

The Senior Hardware Verification/Test Engineer will play a critical role as a part of the verification and test team. He will work on IEC testing and other hardware testing, temperature testing (protocol, results, reports), Design specs review/approval etc.

Key Responsibilities:

• Perform hardware functional verification and testing
• Develop and update hardware test protocols for medical device hardware components
• Perform design specifications review and approval for new and existing medical devices
• Identify and validate alternative components to address obsolescence issues in medical device hardware
• Collaborate with cross-functional teams to ensure compliance with regulatory standards and quality requirements
• Contribute to risk analysis and management processes for medical device hardware
• Participate in design reviews and provide technical expertise throughout the product development lifecycle
• Conduct IEC 60601 and other certification testing for medical electrical equipment

Required Qualifications:

• • • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related field
    • 5 to 7 years of experience in hardware engineering for medical devices
    • In-depth knowledge of IEC 60601 standards and testing procedures
    • Familiarity with medical device regulatory requirements (e.g., FDA, CE marking)
    • Experience with obsolescence management and component sourcing for long-lifecycle products
    • Strong analytical and problem-solving skills
    • Excellent communication and documentation abilities

Preferred Qualifications:

• Knowledge of ISO 13485 and FDA Quality System Regulation
• Experience with embedded systems and software-hardware integration
• Familiarity with risk management (ISO 14971) standards

Key Competencies:

• Attention to detail and commitment to quality
• Ability to work independently and as part of a team
• documentation skills