Katalyst Healthcares and Life Sciences
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.