Engineer 2, Design & Development

Role Overview

• Execute design and development projects ensuring all engineering activities follow established processes, technical standards, regulatory requirements, and quality management systems
• Track milestones, document design decisions, and ensure deliverables are completed on time and within scope
• Adhere to international and local regulations/standards throughout the project lifecycle, ensuring all engineering activities align with Cook Medical's Quality Management System and local regulatory requirements
• Apply engineering expertise to support product development and transfer from concept to commercial launch, ensuring projects progress on time and in compliance
• Drive technological innovation and contribute to the company's intellectual property portfolio through invention disclosures and patent applications
• Collaborate with Engineering, Manufacturing, Quality, Regulatory, Marketing, and external partners to integrate resources and achieve project objectives
• Provide engineering support for the implementation and improvement of the local Quality Management System (QMS)
• Prepare and maintain documentation related to product concepts, design drawings, manufacturing processes, etc., ensuring compliance with regulatory and corporate quality requirements
• Maintain accurate and timely project records and reports to support internal audits and external submissions
• Work effectively with global teams, communicating proactively to achieve cross-regional project goals
• Strictly comply with safety policies and procedures to ensure a safe working environment
• Develop and maintain a thorough understanding of Cook Medical policies, procedures, and systems
• Stay informed of updates in medical device regulations, standards, and guidance documents to ensure ongoing compliance

Requirements

• Bachelor’s degree required, preferably in Engineering, Science or a related field
• Minimum 3 years relevant experience is desired, preferably within the medical device industry
• Knowledge of relevant ISO, EU, FDA medical device standards regulations is required
• Strong technical writing skills
• Proficiency in engineering software CAD required
• Excellent communication skills in both English and Chinese required
• Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge is desired
• Ability to collaborate effectively with local and global teams
• Detail-oriented with strong problem-solving and project management skills
• Execution of projects in a timely effective manner
• Knowledge of anatomy and physiology desired
• Self-motivated learner with the ability to work collaboratively and drive execution across functions
• Willingness and availability to travel on company business
• Fluency in Artificial Intelligence (AI) and data concepts

Benefits

• Comprehensive engineering support
• Opportunity to enhance intellectual property portfolio
• Collaboration with global teams