Urgent Need Senior Hardware Verification/test Engineer – Santa Rosa, CA – Contract

 Senior Hardware Verification/test Engineer

Experience: 5 to 8 years

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

·         Strong documentation skills

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