Qualifications

• Minimum 5 years experience in medical device engineering or related field.
• Strong understanding of regulatory compliance and risk management.
• Hands-on experience troubleshooting electromechanical devices.
• Background in Systems Engineering and structured problem-solving methodologies.
• Proficiency in statistical testing methods and failure mode analysis (FMEA).

Responsibilities

• Conduct root cause analysis and implement corrective actions for product issues.
• Develop and execute test plans for verification, validation, and compliance.
• Evaluate risks associated with product changes and propose mitigation strategies.
• Collaborate with cross-functional teams to implement product updates.
• Ensure design for manufacturability, testability, and reliability by collaborating with suppliers.
• Maintain thorough documentation of design changes, testing results, and risk assessments.

Benefits

• Comprehensive health and wellness programs.
• Opportunities for professional development and continuing education.
• Flexible work schedule and work-life balance initiatives.
• Collaborative team environment with cross-functional engagement.
• Access to cutting-edge technology and resources.