Hardware Test Engineer at RISHAAR LLC
Santa Rosa, CA 95401
About the Job
Position: Senior Hardware Verification/Test Engineer
Location: Santa Rosa, CA (onsite)
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
