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Senior Hardware Verification and Test Engineer

2 months ago

Santa Rosa, California, United States RISHAAR LLC Full time
Job Description

RISHAAR LLC is seeking a highly skilled Senior Hardware Verification and Test Engineer to join our team.

Key Responsibilities:
  • Develop and execute comprehensive test plans to ensure the quality and reliability of medical devices.
  • Collaborate with cross-functional teams to design and implement hardware verification and testing strategies.
  • Analyze and interpret test results to identify areas for improvement and implement corrective actions.
  • Stay up-to-date with industry standards and regulations, including IEC 60601 and FDA guidelines.
  • Develop and maintain technical documentation, including test plans, procedures, and reports.
Requirements:
  • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field.
  • 5-7 years of experience in hardware engineering for medical devices.
  • Proven expertise in IEC 60601 standards and testing procedures.
  • Familiarity with medical device regulatory requirements, including FDA and CE marking.
  • Strong analytical and problem-solving skills, with 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.