Engineer 2, Design & Development
Cook Group
full-time
Posted on:
Location Type: Office
Location: Shanghai • China
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About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
engineeringtechnical writingmechanical designproject managementCADanatomyphysiologymedical device materialsISO standardsFDA regulations
Soft Skills
communicationcollaborationdetail-orientedproblem-solvingself-motivatedexecutionproactive communicationteamworkadaptabilitytime management
Certifications
Bachelor’s degree in EngineeringBachelor’s degree in ScienceISO certificationFDA compliance trainingmedical device certification