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:
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- 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
- Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related field
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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
Additional information
All your information will be kept confidential according to EEO guidelines.
Alten Calsoft Labs
ALTEN Calsoft Labs is an Enterprise IT and product engineering service provider founded in 1992, acquired by the French-based multinational engineering service provider ALTEN in 2011.
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