rahul@systellartechnologies.com
https://www.linkedin.com/in/rahul-antil-0b3637264/
Title : Senior Hardware Verification/test Engineer (IEC 60601/obsolescence management)
Experience : 5 to 8 years
Job location : Santa Rosa, CA
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
Rahul Antil
rahul@systellartechnologies.com
https://www.linkedin.com/in/rahul-antil-0b3637264/
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