Alten Calsoft Labs
Electrical Engineer Medical Device
Alten Calsoft Labs, Santa Rosa, California, us, 95402
Job Description
Electrical engineering background - hardware testing
EMI/EMC Testing
IEC 60601 - 1 -2
Obsolescence 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), and design specs review/approval.
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
Additional Information:All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr
Electrical engineering background - hardware testing
EMI/EMC Testing
IEC 60601 - 1 -2
Obsolescence 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), and design specs review/approval.
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
Additional Information:All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr