Description

You will perform hardware functional verification and testing for medical device components.

Responsibilities

• Perform hardware functional verification and testing.
• Develop and update hardware test protocols for medical device components.
• Review and approve design specifications for new and existing medical devices.
• Identify and validate alternative components to mitigate obsolescence issues.
• Conduct IEC 60601 and other certification testing for medical electrical equipment.
• Collaborate with cross-functional teams to ensure regulatory and quality compliance.
• Contribute to risk analysis and management processes.

Required Skills

• 5 to 7 years of hardware engineering experience in the medical device industry.
• In-depth knowledge of IEC 60601 standards and testing procedures.
• Familiarity with FDA and CE marking regulatory requirements.
• Experience with obsolescence management and component sourcing for long-lifecycle products.
• Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field.
• Strong analytical, problem-solving, and documentation skills.

Preferred Skills

• Knowledge of ISO 13485 and FDA Quality System Regulation.
• Experience with embedded systems and software-hardware integration.
• Familiarity with ISO 14971 risk management standards.

Key Skills

Education

Bachelor's degree in Electrical Engineering