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Senior Hardware Verification/Test Engineer

1 month ago

Santa Rosa, United States Evolve Esolutions Full time
Job DescriptionJob Description
  • Job Description for this position. : IEC testing, as required. Resistor temperature testing (protocol, results, reports) Design specs review/approval. Strong communication and interpersonal Skill.(JD below)
  • Experience band : 4-8 years
  • Requested start date for project. ASAP ( can start from next week)
  • Job Location: (Santa Rosa)
  • Total duration of the project: 1 year

Senior Hardware Verification/test Engineer

Experience Band 4 to 8 years

Job location : Santa Rosa

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