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Hardware Verification/test Engineer

  • Full Time, onsite
  • Vakula Technologies Inc
  • Santa Rosa, United States of America
Salary undisclosed

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Position: Hardware Verification/test Engineer

Location: Santa Rosa(Onsite)

Duration: 12+ months

Pay rate: 40/hr W2

Jd

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