Description

Lead hardware functional verification and testing for medical device components, ensuring compliance with regulatory standards.

This role is on-site.

Responsibilities

• Perform IEC 60601 certification testing and hardware functional verification tasks.
• Develop and update hardware test protocols, including resistor temperature testing and reporting.
• Review and approve design specifications for new and existing medical devices.
• Identify and validate alternative components to manage obsolescence for long-lifecycle products.
• Contribute to risk analysis and participate in design reviews throughout the product lifecycle.

Required Skills

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

Preferred Skills

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

Key Skills

Education

Any Graduate