職位描述
設(shè)計控制變更控制程序
【Job Responsibilitie】
1. Plan, Coordinate, and Monitor Feasibility R&D Projects:
- Support the CTO in planning and coordinating cross-disciplinary R&D feasibility studies and projects.
- Define technical requirements, deliverables, and timelines in collaboration with stakeholders and experts.
- Communicate effectively with R&D, Operations, Marketing, Regulatory, Clinical teams, suppliers, and external partners.
- Manage NDAs and contracts with third-party collaborators when needed.
- Provide regular progress reports, meeting minutes, and summaries.
- Support the CTO in planning and coordinating cross-disciplinary R&D feasibility studies and projects.
- Define technical requirements, deliverables, and timelines in collaboration with stakeholders and experts.
- Communicate effectively with R&D, Operations, Marketing, Regulatory, Clinical teams, suppliers, and external partners.
- Manage NDAs and contracts with third-party collaborators when needed.
- Provide regular progress reports, meeting minutes, and summaries.
2. Initiate Formal Project Kick-offs
- Launch formal projects (product life cycle management) upon successful completion of feasibility phases. Create final feasibility study report, assist with responsibility transfer to cite managers.
- Coordinate and transfer information to ensure smooth and successful implementation at project sites.
- Facilitate communication among stakeholders and provide initial support for new projects.
- Launch formal projects (product life cycle management) upon successful completion of feasibility phases. Create final feasibility study report, assist with responsibility transfer to cite managers.
- Coordinate and transfer information to ensure smooth and successful implementation at project sites.
- Facilitate communication among stakeholders and provide initial support for new projects.
3. Support Process Flow with Technical Information Collection
- Gather and analyze technical data and product specifics from marketing materials, patent applications, scientific articles, and key opinion leaders.
- Develop rationales and justifications for project decisions.
- Apply for government-sponsored programs and navigate policies to support innovative developments.
- Gather and analyze technical data and product specifics from marketing materials, patent applications, scientific articles, and key opinion leaders.
- Develop rationales and justifications for project decisions.
- Apply for government-sponsored programs and navigate policies to support innovative developments.
4. Provide Technical Assistance to the CTO
- Compose concise technical summaries and reports.
- Review competitor technologies, products, and analyze key players’ patent portfolios. Closely communicate with Marketing colleagues.
- Offer comprehensive daily technical support to aid strategic decision-making.
- Compose concise technical summaries and reports.
- Review competitor technologies, products, and analyze key players’ patent portfolios. Closely communicate with Marketing colleagues.
- Offer comprehensive daily technical support to aid strategic decision-making.
【Qualification for Employment】
1.Educational degree/major/age- Degree: Minimum Master’s Degree (MSc) in a technical discipline such as Mechanical, Electrical, Optical, Chemical Engineering, or related fields.
- Age: 25–45 years.
2.Relevant work experience
- Industries: Experience in the medical device, pharmaceutical, or medical equipment sectors.
- Project skills: Experience with project coordination and monitoring.
- Preferred: Background in the ophthalmic industry is highly advantageous!
- Industries: Experience in the medical device, pharmaceutical, or medical equipment sectors.
- Project skills: Experience with project coordination and monitoring.
- Preferred: Background in the ophthalmic industry is highly advantageous!
3.Employability skills (relevant vocational competencies matched with job requirements, ranked by importance)
- Industry Experience: Over 5 years in the medical device or pharmaceutical industries.
- Adaptability & Creativity: Demonstrated ability to learn quickly and innovate. Initiative and open-minded!
- Communication: Skilled in building and maintaining effective communication channels among diverse stakeholder groups.
- Project Management: Proficient in project coordination and management, with knowledge of relevant tools and software.
- Technical Proficiency: Experience working with technical and scientific information, including technical study reports, patents and research articles. Ability to summarize information and identify key details.
- Regulatory and QA Knowledge: Understanding the principles of ISO 13485, or 21 CFR, and other Quality Management System (QMS) requirements specific for medical device industry, particularly Design Control and Change Control procedures.
- Additional Skills: Competence in data analysis, statistics, programming, optics, materials, or related areas is a plus.
- Industry Experience: Over 5 years in the medical device or pharmaceutical industries.
- Adaptability & Creativity: Demonstrated ability to learn quickly and innovate. Initiative and open-minded!
- Communication: Skilled in building and maintaining effective communication channels among diverse stakeholder groups.
- Project Management: Proficient in project coordination and management, with knowledge of relevant tools and software.
- Technical Proficiency: Experience working with technical and scientific information, including technical study reports, patents and research articles. Ability to summarize information and identify key details.
- Regulatory and QA Knowledge: Understanding the principles of ISO 13485, or 21 CFR, and other Quality Management System (QMS) requirements specific for medical device industry, particularly Design Control and Change Control procedures.
- Additional Skills: Competence in data analysis, statistics, programming, optics, materials, or related areas is a plus.
4.Additional requirements
- Perfect English, written and spoken, ability to comunicate clearly on technical subjects and use commonly accepted terminology.
- Positive attitude to work and colleagues.
- Perfect English, written and spoken, ability to comunicate clearly on technical subjects and use commonly accepted terminology.
- Positive attitude to work and colleagues.
【崗位職責(zé)】
1. 規(guī)劃、協(xié)調(diào)和管控可行性研發(fā)項(xiàng)目：
- 在CTO的協(xié)助下規(guī)劃和協(xié)調(diào)跨學(xué)科的研發(fā)可行性研究和項(xiàng)目。
- 與利益相關(guān)者和專家合作定義技術(shù)要求、交付成果和時間表。
- 與研發(fā)、運(yùn)營、市場、監(jiān)管、臨床團(tuán)隊、供應(yīng)商和外部合作伙伴有效溝通。
- 在需要時管理與第三方合作者的保密協(xié)議和合同。
- 提供定期進(jìn)度報告、會議記錄和摘要。
2. 啟動正式項(xiàng)目啟動
- 在可行性階段成功完成后，啟動正式項(xiàng)目（產(chǎn)品生命周期管理）。創(chuàng)建最終的可行性研究報告，協(xié)助責(zé)任轉(zhuǎn)移給項(xiàng)目經(jīng)理。
- 協(xié)調(diào)和轉(zhuǎn)移信息以確保項(xiàng)目現(xiàn)場的順利和成功實(shí)施。
- 促進(jìn)利益相關(guān)者之間的溝通，并為新項(xiàng)目提供初步支持。
3. 通過技術(shù)信息收集支持流程
- 收集和分析來自市場資料、專利申請、科學(xué)文章和關(guān)鍵意見領(lǐng)袖的技術(shù)數(shù)據(jù)和產(chǎn)品細(xì)節(jié)。
- 為項(xiàng)目決策制定理由和依據(jù)。
- 申請政府資助項(xiàng)目并導(dǎo)航政策以支持創(chuàng)新發(fā)展。
4. 為CTO提供技術(shù)支持
- 撰寫簡潔的技術(shù)摘要和報告。
- 審查競爭對手的技術(shù)、產(chǎn)品，并分析關(guān)鍵玩家的專利組合。與市場同事密切溝通。
- 提供全面的日常技術(shù)支持以協(xié)助戰(zhàn)略決策。
- 在CTO的協(xié)助下規(guī)劃和協(xié)調(diào)跨學(xué)科的研發(fā)可行性研究和項(xiàng)目。
- 與利益相關(guān)者和專家合作定義技術(shù)要求、交付成果和時間表。
- 與研發(fā)、運(yùn)營、市場、監(jiān)管、臨床團(tuán)隊、供應(yīng)商和外部合作伙伴有效溝通。
- 在需要時管理與第三方合作者的保密協(xié)議和合同。
- 提供定期進(jìn)度報告、會議記錄和摘要。
2. 啟動正式項(xiàng)目啟動
- 在可行性階段成功完成后，啟動正式項(xiàng)目（產(chǎn)品生命周期管理）。創(chuàng)建最終的可行性研究報告，協(xié)助責(zé)任轉(zhuǎn)移給項(xiàng)目經(jīng)理。
- 協(xié)調(diào)和轉(zhuǎn)移信息以確保項(xiàng)目現(xiàn)場的順利和成功實(shí)施。
- 促進(jìn)利益相關(guān)者之間的溝通，并為新項(xiàng)目提供初步支持。
3. 通過技術(shù)信息收集支持流程
- 收集和分析來自市場資料、專利申請、科學(xué)文章和關(guān)鍵意見領(lǐng)袖的技術(shù)數(shù)據(jù)和產(chǎn)品細(xì)節(jié)。
- 為項(xiàng)目決策制定理由和依據(jù)。
- 申請政府資助項(xiàng)目并導(dǎo)航政策以支持創(chuàng)新發(fā)展。
4. 為CTO提供技術(shù)支持
- 撰寫簡潔的技術(shù)摘要和報告。
- 審查競爭對手的技術(shù)、產(chǎn)品，并分析關(guān)鍵玩家的專利組合。與市場同事密切溝通。
- 提供全面的日常技術(shù)支持以協(xié)助戰(zhàn)略決策。
【任職資格】
1. 教育程度/專業(yè)/年齡
- 學(xué)位：機(jī)械、電氣、光學(xué)、化學(xué)工程或相關(guān)專業(yè)的碩士及以上學(xué)位。
- 年齡：25至45歲。
2. 相關(guān)工作經(jīng)驗(yàn)
- 在醫(yī)療器械、制藥或醫(yī)療設(shè)備領(lǐng)域有經(jīng)驗(yàn)。
- 有項(xiàng)目協(xié)調(diào)和管控經(jīng)驗(yàn)。
- 具備眼科行業(yè)背景優(yōu)先考慮
3. 技能（與工作要求相匹配的相關(guān)職業(yè)技能，按重要性排序）
- 行業(yè)經(jīng)驗(yàn)：在醫(yī)療器械或制藥行業(yè)超過5年的工作經(jīng)驗(yàn)。
- 適應(yīng)性與創(chuàng)造力：展現(xiàn)出快速學(xué)習(xí)和創(chuàng)新的能力。積極主動和思維開放！
- 溝通：擅長建立和維護(hù)有效的溝通渠道。
- 項(xiàng)目管理：熟練進(jìn)行項(xiàng)目協(xié)調(diào)和管理，了解相關(guān)工具和軟件。
- 技術(shù)熟練度：有處理技術(shù)性和科學(xué)性信息的經(jīng)驗(yàn)，包括技術(shù)研究報告、專利和研究文章。能夠總結(jié)信息并識別關(guān)鍵細(xì)節(jié)。
- 法規(guī)和質(zhì)量保證知識：理解ISO13485或21CFR以及其他針對醫(yī)療器械行業(yè)的質(zhì)量管理系統(tǒng)（QMS）要求，特別是設(shè)計控制和變更控制程序。
- 其他技能：數(shù)據(jù)分析、統(tǒng)計、編程、光學(xué)、材料或相關(guān)領(lǐng)域的技能是加分項(xiàng)。
4. 其他要求
- 英語能熟練運(yùn)用于書面或口語，并且能夠在專業(yè)技術(shù)上清晰溝通并使用術(shù)語。
- 協(xié)同意識佳、工作態(tài)度積極。
- 學(xué)位：機(jī)械、電氣、光學(xué)、化學(xué)工程或相關(guān)專業(yè)的碩士及以上學(xué)位。
- 年齡：25至45歲。
2. 相關(guān)工作經(jīng)驗(yàn)
- 在醫(yī)療器械、制藥或醫(yī)療設(shè)備領(lǐng)域有經(jīng)驗(yàn)。
- 有項(xiàng)目協(xié)調(diào)和管控經(jīng)驗(yàn)。
- 具備眼科行業(yè)背景優(yōu)先考慮
3. 技能（與工作要求相匹配的相關(guān)職業(yè)技能，按重要性排序）
- 行業(yè)經(jīng)驗(yàn)：在醫(yī)療器械或制藥行業(yè)超過5年的工作經(jīng)驗(yàn)。
- 適應(yīng)性與創(chuàng)造力：展現(xiàn)出快速學(xué)習(xí)和創(chuàng)新的能力。積極主動和思維開放！
- 溝通：擅長建立和維護(hù)有效的溝通渠道。
- 項(xiàng)目管理：熟練進(jìn)行項(xiàng)目協(xié)調(diào)和管理，了解相關(guān)工具和軟件。
- 技術(shù)熟練度：有處理技術(shù)性和科學(xué)性信息的經(jīng)驗(yàn)，包括技術(shù)研究報告、專利和研究文章。能夠總結(jié)信息并識別關(guān)鍵細(xì)節(jié)。
- 法規(guī)和質(zhì)量保證知識：理解ISO13485或21CFR以及其他針對醫(yī)療器械行業(yè)的質(zhì)量管理系統(tǒng)（QMS）要求，特別是設(shè)計控制和變更控制程序。
- 其他技能：數(shù)據(jù)分析、統(tǒng)計、編程、光學(xué)、材料或相關(guān)領(lǐng)域的技能是加分項(xiàng)。
4. 其他要求
- 英語能熟練運(yùn)用于書面或口語，并且能夠在專業(yè)技術(shù)上清晰溝通并使用術(shù)語。
- 協(xié)同意識佳、工作態(tài)度積極。
工作地點(diǎn)
高視創(chuàng)新科技有限公司
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職位發(fā)布者
李女士/HRBP
立即溝通
高視醫(yī)療集團(tuán)高視醫(yī)療[2047.HK]深耕眼科 20余年，是中國本土最大的眼科醫(yī)療器械科技集團(tuán)，依托于地跨中國、荷蘭、德國三地的研發(fā)生產(chǎn)平臺及上游 19家合作伙伴，持續(xù)為客戶提供涵蓋眼科全部七個主要亞專科的優(yōu)質(zhì)產(chǎn)品及服務(wù)，截止目前產(chǎn)品已銷往全球 51個國家和地區(qū)。高視醫(yī)療科技集團(tuán)(Gaush Meditech)于 2022年12月 12日在香港主板成功上市，這是高視醫(yī)療發(fā)展史上重要的里程碑，更是一個嶄新的起點(diǎn)。期望能與優(yōu)秀的同學(xué)們一同邁向更美好的未來！
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