Qualifications

• Bachelor's in Mechanical, Electrical, Biomedical, or Quality Engineering; or equivalent trade experience
• 2-5 years engineering experience in medical device or regulated industries
• Knowledge of ISO 13485, FDA QSR, and ISO 14971 standards
• Experience in planning and executing Verification and Validation for electromechanical devices
• Proficient in writing and executing equipment IQ/OQ/PQ and Test Method Validation
• Skilled in data acquisition systems and analysis tools like MATLAB or Minitab
• Hands-on experience with mechanical test equipment

Responsibilities

• Plan and execute Design Verification and Validation for complex devices
• Design, develop, validate, and execute test methods for system functionality
• Conduct exploratory testing to support early-stage design inputs
• Design and assemble custom test fixtures and automated equipment
• Write and execute protocols and reports for testing software and hardware
• Author test protocols, data sheets, and final reports and assist in manufacturing procedures
• Ensure compliance with quality regulations and risk management standards
• Apply statistical techniques for data analysis and testing datasets
• Communicate test findings and risks to relevant stakeholders

Benefits

• Opportunities to work in a compliant and regulated environment
• Engagement in diverse project phases from R&D to Production
• Hands-on experience with cutting-edge medical device technologies
• Collaboration with multidisciplinary project teams
• Potential for professional growth in a regulated industry