Ensure alignment of technical documentation to EU Medical Device Regulation (MDR), FDA, ISO13485, EN60601 for the
entire range of endoscopic legacy product portfolio.
• Definition, adaptation, and improvement of processes for technical documentation according to MDR.
• Coordination of updating documentation with product managers.
• Coordination of CE regulatory approvals. Internal Auditing.
• Requirements definition and software testing for SAP Computer Software Validation.

确保技术文件符合欧盟医疗器械法规（MDR）、美国食品药品监督管理局、ISO13485、EN60601
全系列内窥镜遗留产品组合。
•根据MDR定义、调整和改进技术文件编制过程。
•与产品经理协调更新文档。
•协调CE监管批准。内部审计。
•SAP计算机软件验证的需求定义和软件测试。

Leading end-to-end delivery of multi-million-euro projects for ceramic implant (for hip, shoulder, spine, and knee) from conception to serial production. Supervise team of up to 20, draft status reports, and update management and stakeholders. Uncover customers’ requirements and develop product accordingly by coordinating with manufacturing and testing teams, including product, R&D, production, and quality managers. Monitor product quality, assess and mitigate potential risks and prepare reviews.
● Reduced time for project monitoring by 50% by building and maintaining IT tools.
● Led and delivered multiple projects on-time, under budget, and in in with client expectations.
● Spearheaded numerous Ceramic research projects including 3D printing.
● Created development process according with ISO 13485 and FDA 21 CFR 820.30; accepted without deviation by TUEV ISO 13485 Audits.
● Developed project management approaches based on Scrum for development activities; presented in a Project Management Congress in 2018.

领导数百万欧元陶瓷植入物（髋关节、肩部、脊椎和膝盖）项目的端到端交付，从构思到批量生产。监督最多20人的团队，起草状态报告，并更新管理层和利益相关者。通过与生产和测试团队（包括产品、研发、生产和质量经理）的协调，发现客户的需求并相应地开发产品。监控产品质量，评估和减轻潜在风险，并准备审查。
● 通过构建和维护IT工具，将项目监控时间减少了50%。
● 按时、低于预算、符合客户期望地领导和交付多个项目。
● 领导了包括3D打印在内的众多陶瓷研究项目。
● 根据ISO 13485和美国食品药品监督管理局21 CFR 820.30创建开发流程；TUEV ISO 13485审核无偏差地接受。
● 开发了基于Scrum的开发活动项目管理方法；在2018年的项目管理大会上发表。

Ensured end-to-end delivery of three EU-projects having total budget of €15M within time-frame of three-four years; reported to EU commission. Headed international project team of about 20 partners distributed in EU, US, and UK. Actively engaged in Agile framework projects, including Scrum and eXtreme Programming (XP).
● Developed clinical applications based on personalised muscle-skeletal modelling created from patients’ data.
● Wrote two project grants than granted by EC and UK national funds (€10M)
确保三个欧盟项目的端到端交付，总预算为1500万欧元，时间框架为三四年；向欧盟委员会报告。领导由分布在欧盟、美国和英国的约20个合作伙伴组成的国际项目团队。积极参与敏捷框架项目，包括Scrum和极限编程（XP）。
● 开发了基于患者数据创建的个性化肌肉骨骼模型的临床应用程序。
● 编写了两个项目赠款，比EC和英国国家基金提供的赠款多（1000万欧元）

Developed Agile tools based on XP to strengthen collaboration of the distributed team.
Published a paper in Orthopaedic Journal.

Led two EU-projects with total budget of €15M, with a time-frame of three-four years. Supervised all project activities and reported to EU commission. Steered a highly skilled international team of 20 partners distributed in EU, US and UK. Served as Visiting Project Manager at Technical University of Eindhoven, Nederland from Feb 2011 to Apr 2011.
● Developed Agile tools based on XP to strengthen collaboration of the distributed team.
● Published a paper in Orthopaedic Journal.

领导了两个欧盟项目，总预算为1500万欧元，时间框架为三四年。监督所有项目活动并向欧盟委员会报告。领导一支由20名合作伙伴组成的高技能国际团队，分布在欧盟、美国和英国。2011年2月至2011年4月，在荷兰埃因霍温技术大学担任客座项目经理。
● 开发了基于XP的敏捷工具，以加强分布式团队的协作。
● 在《骨科杂志》上发表论文。