Electrical Engineer (Medical Device) - Alten Calsoft Labs

ALTEN Calsoft Labs is an Enterprise IT and product engineering service provider founded in 1992, Calsoft Labs was acquired by the French Based Multinational Engineering service provider ALTEN , in 2011 with offices in United States, Europe, Singapore and India . The company primarily focuses on Healthcare, Education, Retail and Networking & Telecom industries.

www.altencalsoftlabs.com

Electrical engineering background  - hardware testing

EMI/EMC Testing

IEC 60601 - 1 -2

absolution Management

Senior Electrical Engineer - Onsite

Experience Band 4 to 8 years

Job location : Santa Rosa, California

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

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