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Company Description

Simplified IT is a global IT Staffing and Managed Services company.  We have been rated top 10 staffing companies in the country for 3 years in a row. We serve technology, financial, auto, logistics & distribution companies across the United States, providing either IT staffing or technology solutions — or both. With decades of experience and a nationwide network of highly qualified, certified IT professionals, our goal is to build a lasting relationship with each client based on trust and consistent, reliable services.

Job Description

We are looking for Senior Hardware Verification/Test Engineer Job Location: Santa Rosa, CA (Onsite)

Job Title: Senior Hardware Verification/Test Engineer
Experience Band: 4 to 8 years
Job Location: Santa Rosa, CA (Onsite)
Start Date: ASAP (Can start next week)
Duration: 1 year

Job Description

The Senior Hardware Verification/Test Engineer will play a critical role as part of the verification and test team. The role involves Hardware test engineering, EMI/EMC testing, Temperature testing, IEC61000, testing for 60601-1-1and 60601-1- IEC testing, hardware testing, temperature testing (protocol, results, reports), and design specification review and approval.

Key Responsibilities:

• Perform hardware functional verification and testing.
• Develop and update hardware test protocols for medical device hardware components.
• Perform design specification reviews and approvals 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.

Qualifications

Required Qualifications:

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a 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.
   

  With Warm Regards,
  Monesh Tiwari
  Mobile 949-336-1475
  https://www.linkedin.com/in/monesh-tiwari-627aa718b/

Additional Information

All your information will be kept confidential according to EEO guidelines.