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Job purpose

职位目标

This is an experienced R&D Engineer position, mainly responsible for leading the full-process technical realization of medical devices from design to mass production, collaborating with contract manufacturers and manufacturing teams, including design transfer, process development and qualification, production support, process optimization, and quality system compliance, and participating in cross-departmental collaboration (quality, production, regulations, etc.) Solve engineering problems and promote continuous improvement. The ideal candidate will have an in-depth understanding of medical device systems and practical working experience in the design verification of medical device systems or subsystems.

这是一个经验丰富的医疗器械研发工程师的岗位，主要负责领导医疗器械从设计到量产的全流程技术实现，与委托生产厂商和制造团队合作，包括设计转换、工艺开发和验证、生产支持、流程优化及质量体系合规等，并参与跨部门协作（质量、生产、法规等），解决工程问题并推动持续改进。理想的候选人对医疗器械系统有深入的了解，并在医疗器械系统或子系统的设计验证方面有实际工作经验。

Main Responsibilities, Activities, Duties and Tasks

主要工作职责，活动和任务

• Lead the NPI (new product introduction) and design transfer activities of medical devices, ensuring a seamless transition from design to manufacturing.

领导医疗器械的新产品导入和设计转换活动，确保从设计到制造的无缝过渡。

• Work closely with suppliers to support the development, create and maintain documentation for design transfer, process validation, and compliance with regulatory requirements, qualification and implementation of manufacturing processes validation and improvement for medical devices, including IQ/OQ/PQ protocols, to ensure that all operations are performed with compliance with SOPs and QMS requirements.

与供应商紧密合作，创建并维护设计转移、工艺验证和符合法规要求的文件。支持开发、认证和实施医疗器械的制造工艺确认，包括IQ/OQ/PQ（安装/操作/性能认证）方案，确保所有操作符合SOP和质量体系要求。

• Collaborate with suppliers and manufacturing engineers to optimize product designs for manufacturability and scalability. Provide R&D support to sustain existing products and achieve production goals and priorities.

与供应商和制造工程师合作，优化产品设计的可制造性和可量产性，支持现有产品的维护和实现生产目标和优先事项。

• Perform risk assessments and failure mode effects analysis (FMEA) to ensure product safety and reliability throughout the manufacturing process.

执行风险评估和失效模式影响分析（FMEA），确保产品在整个制造过程中的安全性和可靠性。

• Provide technical product expertise and problem-solving solutions, and support engineering problems or challenges that arise during the production process.

在制造过程中提供技术产品专业知识和问题解决方案，并支持生产过程中出现的工程问题或挑战。

• Engage in continuous improvement initiatives to optimize processes, reduce costs, and enhance product quality, as well as the evaluation and implementation of engineering change at manufacturing side.

参与持续改进，优化流程，降低成本，提高产品质量，以及工程变更的评估和执行。

• Support team tasked with monitoring, analyzing, and reporting product test data, eg, follow the corrective and preventive actions (CAPA), tracking the implementation effect of the measures resulting in effective resolution of quality problems.

支持团队监控、分析和报告产品测试数据，如根据纠正预防措施（CAPA），跟踪措施执行效果，从而有效解决质量问题。

• Support design verification/validation activities, including the development of Qualification Test Plans for medical devices.

支持设计验证/验证活动，包括医疗器械认证测试计划的开发。

• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success and contribute to the project as a team member.

与研发、质量、生产、法规、临床、市场和项目管理协同工作，确保项目成功。

• Self-motivated, proactive, ability to independently analyze and solve problems.

具有自我激励、积极主动，独立分析和解决问题的能力；

• Comfortable working in a cross-culture environment, strong written, verbal and, communication and presentation skills in both English and Chinese.

适应在跨文化环境中工作，良好的中英文书面、口头沟通能力。

• Other work assigned by superior.

上级领导交代的其他工作。

Company introduction

Bracco is a world-renowned medical group. Founded in Italy in 1927, Bracco has been operating in more than 100 markets worldwide, with more than 3,960 employees and annual revenue of more than 2 billion euros, about 88% of which comes from overseas markets outside Italy. The group invests nearly 9% of its annual net sales in research and development (imaging diagnosis and medical devices) and owns more than 2,200 patents. Bracco group is headquartered in Milan, Italy. Bracco group is consisted of three entites - the Bracco imaging diagnosis company (diagnostic imaging), Bracco medical system (medical devices and high-end contrast agent injection system), and the Italian diagnostic center specializing in clinical diagnosis. Bracco imaging diagnostics is an original research and development company whose success has witnessed the history of the entire imaging industry. The company's unique products, covering radiation, CT, nuclear magnetic resonance, ultrasound and nuclear medicine and other fields. In 2001, Bracco group acquired ACIST, which provides high-quality medical devices and high-end contrast injection systems for the field of radiation and radiotherapy. ACIST is headquartered in Minneapolis and has offices in Europe and Asia. The advanced equipment of ACIST has been adopted by well-known medical centers in more than 40 countries, benefiting tens of millions of patients worldwide in cardiovascular angiography. In addition, the group has opened an advanced polyclinic in Milan, the Italian diagnostic center (CDI), which provides services directly to patients for more than 30 years. The ambulatory center offers a full range of preventive, diagnostic, rehabilitation and personalized services, with a particular focus on radiosurgery and same-day surgery.