SeniorHardwareVerification test Engineer | Santa Rosa, CA

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Senior Hardware Verification/test Engineer
location : Santa Rosa, CA

Onsite position
Long Term

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
John Daniel
Recruiter
Cell:212-404-7339
Concord Id:
 john.Daniel@concorditsystems.com

Concord IT Systems, Inc – Project & Staffing Solutions
(Concord IT Systems is an E-Verified Employer)

CITS


From:
John Daniel,
Concord IT Systems, Inc
john.daniel@concorditsystems.com
Reply to:   john.daniel@concorditsystems.com