DCM Infotech Limited
Senior Hardware Verification/Test Engineer
DCM Infotech Limited, Santa Rosa, California, us, 95402
Job Description for Senior Hardware Verification/Test EngineerThe Senior Hardware Verification/Test Engineer will play a critical role as part of the verification and test team. He will work on IEC testing and other hardware testing, temperature testing (protocol, results, reports), and design specs review/approval.Experience Band:
4 to 8 yearsRequested Start Date:
ASAP (can start from next week)Total Duration of the Project:
1 yearKey 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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4 to 8 yearsRequested Start Date:
ASAP (can start from next week)Total Duration of the Project:
1 yearKey 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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