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Senior Hardware Verification or test Engineer at Santa Rosa, California, USA
Email: angel.shelcy@concorditsystems.com
From:

Angel Shelcy,

Concord IT Systems Inc

angel.shelcy@concorditsystems.com

Reply to: angel.shelcy@concorditsystems.com

Greetings from CONCORD IT Systems Inc.,

Role: 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, and 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

Thanks & Regards

Angel Shelcy

Sr. Technical Recruiter

Contact : 872-276-8828

Email Id:

Angel.Shelcy@concorditsystems.com

https://www.linkedin.com/in/angel-shelcy-b3108a187/

CONCORD IT SYSTEMS

https://concorditsystems.com/

Keywords: information technology container edition California Idaho
Senior Hardware Verification or test Engineer
angel.shelcy@concorditsystems.com
angel.shelcy@concorditsystems.com
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Wed Jan 29 07:24:00 UTC 2025

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Location: Santa Rosa, California