Hardware Verificationtest Engineer
Hardware Verificationtest Engineer
Posted on :
16-09-2024
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Job Description
Position: Hardware Verification/test Engineer
Location: Santa Rosa(Onsite)
Duration: 12 months
Pay rate: 40/hr W2
JD:
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 crossfunctional 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:
- Bachelors degree in Electrical Engineering Biomedical Engineering or related field
- 5 to 7 years of experience in hardware engineering for medical devices
- Indepth 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 longlifecycle products
- Strong analytical and problemsolving skills
- Excellent communication and documentation abilities
Preferred Qualifications:
- Knowledge of ISO 13485 and FDA Quality System Regulation
- Experience with embedded systems and softwarehardware 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
Employment Type
Full Time
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