What are the responsibilities and job description for the Senior Hardware Verification/test Engineer (Medical Devices) position at Systellar Technologies?
Title- Senior Hardware Verification/test Engineer (Medical devices)
Job location : Santa Rosa- CA Onsite
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 skill
