Job Details

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 life cycle.
• Conduct IEC 60601 and other certification testing for medical electrical equipment.

• 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 skillsExcellent communication and documentation abilities.
• Knowledge of ISO 13485 and FDA Quality System Regulation.
• Experience with embedded systems and software-hardware integration.
• Familiarity with risk management (ISO 14971) standards.
• Attention to detail and commitment to quality.
• Ability to work independently and as part of a team.
• documentation skills.