Engineer 2, Design & Development

The Design & Development Engineer is responsible for supporting the company's new product development and manufacturing transfer strategy for the Chinese market. This role will provide comprehensive engineering support across new product development and manufacturing transfer activities, ensuring that all products and processes meet Cook Medical's global quality system and comply with local regulatory requirements. This role will also play a key role in facilitating successful product registration and launch within China and other global markets.

• 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.
• Technical Development & Innovation
• Drive technological innovation and contribute to the company's intellectual property portfolio through invention disclosures and patent applications.
• Continuously stay updated on medical, biomedical, and engineering developments relevant to the company's product lines.
• Cross-functional Collaboration & Support
• 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).
• Documentation & Knowledge Management
• 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.
• Collaboration & Safety Culture
• 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.
• Systems & Regulatory Awareness
• 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.

• Work across Global R&D, Cook Medical Quality Systems, and functional stakeholders in the divisions, functional units, and operational units to develop and implement global policies and procedures for Design Controls, Process Development, and Risk Management.
• Develop and maintain an understanding of applicable standards, regulations, and guidance documents affect Design Controls, Process Development, and Risk Management.
• Coordinate implementation of global policies and procedures with local sites and Global R&D Operations Design Assurance personnel. Support other Cook companies as needed to implement global quality system policies and procedures.
• Represent Cook Medical in internal / external audits and act on assigned audit responses / CAPAs. Monitor Design Controls, Process Development, and Risk Management CAPAs and internal / external audit feedback from the manufacturing operations entities' quality systems and evaluate impacts to Cook Medical’s global policies and procedures.
• Participate in the development and deployment of training:
• o Develop training materials and visual aids to support procedures and policies, using smart approaches with worked examples.
• o Coordinate and conduct training with users globally on quality system policies and procedures.
• o Drive consistency across Cook Medical in the approaches to Design Controls, Process Development, and Risk Management
• Maintain our culture, values and commitment to ethics and compliance by recognising, demonstrating, and enforcing appropriate and compliant behaviour.
• Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards, including Cook policies.
• Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.