Blog

Hi folks,

Hope you are doing well.

Title: Senior Hardware Verification/test Engineer

Experience Band 4 to 8 years

Location : Santa Rosa, CA(Onsite)

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 & Regards