Hardware Verification/test Engineer

Concord IT Systems

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

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Vacancy posted 4 days ago

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