主要挑戰(zhàn):

1、持續(xù)推進工藝研發(fā)工作，突破現(xiàn)有球囊/導管制造方法的局限性，保證在質(zhì)量、成本和效率上擁有絕對競爭力；
2、球囊導管介入8年以上產(chǎn)品研發(fā)或工藝經(jīng)驗，植入/介入產(chǎn)品領(lǐng)域8年以上產(chǎn)品研發(fā)或工藝經(jīng)驗，5年以上技術(shù)團隊管理經(jīng)驗團隊規(guī)模不少于5人；

教育及經(jīng)歷:

1、博士及以上學歷，高分子材料及相關(guān)專業(yè)；
2、球囊導管介入5年以上產(chǎn)品研發(fā)或工藝經(jīng)驗，植入/介入產(chǎn)品領(lǐng)域8年以上經(jīng)驗，5年以上技術(shù)團隊管理經(jīng)驗，團隊規(guī)模不少于5人；
3、有特殊貢獻者可放寬；

個人屬性:

1、能洞悉行業(yè)競品產(chǎn)品優(yōu)劣勢，未來產(chǎn)品技術(shù)方向，具備產(chǎn)品策劃與開發(fā)，有項目管理經(jīng)驗和供應(yīng)鏈管理經(jīng)驗；
2、有良好的溝通、協(xié)作、學習能力，具備人才梯隊化管理能力、自我驅(qū)動能力強，有企業(yè)家精神。

主要挑戰(zhàn):

1、新區(qū)域新客戶挖掘、增加客戶粘性；
2、關(guān)注市場動態(tài)，行業(yè)變化，從而發(fā)現(xiàn)新機遇。

教育及經(jīng)歷:

1、碩士及以上學歷，工科類專業(yè)背景優(yōu)先；
2、3年以上To B 直銷經(jīng)驗，3年以上醫(yī)療器械行業(yè)經(jīng)驗。

個人屬性:

1、積極主動，有自控力。有良好的客戶服務(wù)意識，有介入植入醫(yī)療器械背景、了解金屬材料部件產(chǎn)品優(yōu)先；
2、能適應(yīng)出差，出差比例大于50% 。

主要挑戰(zhàn):

1、業(yè)內(nèi)前沿技術(shù)的鉆研，推動新技術(shù)新材料的應(yīng)用；
2、整合資源，推進項目節(jié)奏，快速進行新產(chǎn)品新項目孵化量產(chǎn)。

教育及經(jīng)歷:

1、博士及以上學歷，高分子材料、金屬材料、紡織材料及相關(guān)專業(yè)；
2、3年以上產(chǎn)品研發(fā)，植入醫(yī)療產(chǎn)品相關(guān)工作經(jīng)驗；
3、有特殊貢獻者可放寬；

個人屬性:

1、熟練掌握材料加工專業(yè)知識；
2、英語聽說讀寫熟練，具備較好的溝通能力、協(xié)調(diào)能力以及組織能力。

主要挑戰(zhàn):

1、優(yōu)化產(chǎn)品穩(wěn)定性，提升產(chǎn)品質(zhì)量；
2、降本增效，新工藝開發(fā)及風險把控。

教育及經(jīng)歷:

1、博士及以上學歷，高分子材料、金屬材料、紡織材料及相關(guān)專業(yè)；
2、2年以上技術(shù)類相關(guān)工作經(jīng)驗，2年醫(yī)療行業(yè)或高分子行業(yè)相關(guān)工作經(jīng)驗；
3、有特殊貢獻者可放寬；

個人屬性:

1、熟悉材料加工工藝，了解精益生產(chǎn)和六西格瑪，并能提高產(chǎn)品質(zhì)量，實現(xiàn)產(chǎn)品優(yōu)化；
2、具備較好的溝通協(xié)作能力、擁有獨立分析解決問題能力，并能持續(xù)學習，有一定抗壓力。

主要挑戰(zhàn):

1、根據(jù)產(chǎn)品及產(chǎn)線發(fā)展，策劃質(zhì)量管理方案、推動質(zhì)量改進，提高產(chǎn)品質(zhì)量；
2、持續(xù)推動質(zhì)量風險預防、控制和改善，提升來料、制程、成品質(zhì)量，降低客訴。

教育及經(jīng)歷:

1、博士及以上學歷，高分子材料、金屬材料、紡織材料及相關(guān)專業(yè)；
2、5年以上同崗位經(jīng)驗，有醫(yī)療器械行業(yè)技術(shù)背景者優(yōu)先；
3、有特殊貢獻者可放寬；

個人屬性:

1、了解醫(yī)療器械相關(guān)法規(guī)標準和ISO13485、有新項目質(zhì)量管理經(jīng)驗、有FMEA和質(zhì)量相關(guān)統(tǒng)計能力，熟練運用質(zhì)量工具，熟悉六西格瑪管理；
2、具備問題分析、溝通及協(xié)作能力、時間管理及抗壓能力、心智與心理成熟度、創(chuàng)新能力。

主要挑戰(zhàn):

● 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.

教育及經(jīng)歷:

● 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.

個人屬性:

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

主要挑戰(zhàn):

● 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.

教育及經(jīng)歷:

● 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.

個人屬性:

● 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.