主要挑战:

1、持续推进工艺研发工作，突破现有球囊/导管制造方法的局限性，保证在质量、成本和效率上拥有绝对竞争力；
2、球囊导管介入8年以上产品研发或工艺经验，植入/介入产品领域8年以上产品研发或工艺经验，5年以上技术团队管理经验团队规模不少于5人；

教育及经历:

1、博士及以上学历，高分子材料及相关专业；
2、球囊导管介入5年以上产品研发或工艺经验，植入/介入产品领域8年以上经验，5年以上技术团队管理经验，团队规模不少于5人；
3、有特殊贡献者可放宽；

个人属性:

1、能洞悉行业竞品产品优劣势，未来产品技术方向，具备产品策划与开发，有项目管理经验和供应链管理经验；
2、有良好的沟通、协作、学习能力，具备人才梯队化管理能力、自我驱动能力强，有企业家精神。

主要挑战:

1、新区域新客户挖掘、增加客户粘性；
2、关注市场动态，行业变化，从而发现新机遇。

教育及经历:

1、硕士及以上学历，工科类专业背景优先；
2、3年以上To B 直销经验，3年以上医疗器械行业经验。

个人属性:

1、积极主动，有自控力。有良好的客户服务意识，有介入植入医疗器械背景、了解金属材料部件产品优先；
2、能适应出差，出差比例大于50% 。

主要挑战:

1、业内前沿技术的钻研，推动新技术新材料的应用；
2、整合资源，推进项目节奏，快速进行新产品新项目孵化量产。

教育及经历:

1、博士及以上学历，高分子材料、金属材料、纺织材料及相关专业；
2、3年以上产品研发，植入医疗产品相关工作经验；
3、有特殊贡献者可放宽；

个人属性:

1、熟练掌握材料加工专业知识；
2、英语听说读写熟练，具备较好的沟通能力、协调能力以及组织能力。

主要挑战:

1、优化产品稳定性，提升产品质量；
2、降本增效，新工艺开发及风险把控。

教育及经历:

1、博士及以上学历，高分子材料、金属材料、纺织材料及相关专业；
2、2年以上技术类相关工作经验，2年医疗行业或高分子行业相关工作经验；
3、有特殊贡献者可放宽；

个人属性:

1、熟悉材料加工工艺，了解精益生产和六西格玛，并能提高产品质量，实现产品优化；
2、具备较好的沟通协作能力、拥有独立分析解决问题能力，并能持续学习，有一定抗压力。

主要挑战:

1、根据产品及产线发展，策划质量管理方案、推动质量改进，提高产品质量；
2、持续推动质量风险预防、控制和改善，提升来料、制程、成品质量，降低客诉。

教育及经历:

1、博士及以上学历，高分子材料、金属材料、纺织材料及相关专业；
2、5年以上同岗位经验，有医疗器械行业技术背景者优先；
3、有特殊贡献者可放宽；

个人属性:

1、了解医疗器械相关法规标准和ISO13485、有新项目质量管理经验、有FMEA和质量相关统计能力，熟练运用质量工具，熟悉六西格玛管理；
2、具备问题分析、沟通及协作能力、时间管理及抗压能力、心智与心理成熟度、创新能力。

主要挑战:

● Cultural differences: Different countries and regions have diverse cultural backgrounds and values, which can result in variations in product positioning, marketing, and sales strategies. Understanding and adapting to the local culture is crucial for successful sales.
● Legal and regulatory issues: Different countries and regions have varying laws and regulations, particularly regarding trade, product standards, and intellectual property. You need to understand and comply with the applicable laws and regulations to ensure compliant operations.

教育及经历:

● Bachelor's degree or higher, preferably in Polymer Materials.
● Fluent English; knowledge of Spanish or Portuguese is preferred. Familiarity with the local medical device market environment. 5+ years of business development experience in the medical device or polymer material application field.

个人属性:

● Ability to independently develop customers, negotiate, and communicate internally and externally with multiple parties.
● Proactive, team-oriented, and adaptable to business trips.

主要挑战:

● Regulations and Compliance: The medical device industry is subject to strict regulations and compliance requirements. As a quality manager, you need to ensure that products comply with these regulations and standards and that company operations align with relevant requirements.
● Quality Control: Quality control is crucial in the medical device industry as product quality directly affects patient health and safety. You need to ensure that the company's quality management system operates effectively, including the ability to detect, assess, and resolve quality issues.
● Risk Management: Medical device manufacturing involves certain risks, including product failures, safety issues, and legal liabilities. As a quality manager, you need to effectively manage and mitigate these risks to ensure the company's reputation and interests are not compromised.

教育及经历:

● Bachelor's degree or above in science and engineering. Advanced degree preferred.
● 7+ years of experience in quality-related roles, preferably in a manufacturing environment.

个人属性:

● Familiarity with ISO 13485 quality system and regulatory standards such as FDA QSR 820 and Part 211.
● Experience in constructing quality system documents and conducting compliance audits.
● Strong presentation skills and experience as a trainer.
● Excellent interpersonal skills with a proven ability to effectively interact with multiple organizational units.
● Proficient in the application of quality tools such as FMEA, statistical analysis, process validation, etc.