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Immediate Position for Hardware Verification test engineer at Santa Rosa, CA at Santa Rosa, California, USA
Email: aiyana.rose@concorditsystems.com
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From:

Aiyana Rose,

Concord IT Systems

aiyana.rose@concorditsystems.com

Reply to:   aiyana.rose@concorditsystems.com

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Hello,

Hope you are doing good.

Role: Hardware Verification/test engineer

Location: Santa Rosa, CA

Long term

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

Thanks and Regards,

Aiyana Rose
Senior Team Lead

Cell : +1 209 706 0856
Concord Id :
aiyana.
rose@concorditsystems.com

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Keywords: information technology container edition California Idaho
Immediate Position for Hardware Verification test engineer at Santa Rosa, CA
aiyana.rose@concorditsystems.com
aiyana.rose@concorditsystems.com
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Wed Jan 29 09:32:00 UTC 2025

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