「醫療器材研發工程師」的相似工作

Context The Customer Support (CS) organization is responsible for the installations, qualification, repair and maintenance of the ASML systems at customer sites and is responsible for the necessary transfer of know-how to the customer. Local site Customer Support branches perform these tasks for the customer within the specific region. Executes system Upgrade & Installations and Relocations and provides technical support for other CS activities when needed. Conducts mostly well-defined tasks, with a higher degree of independency and under limited supervision. Requirements Requires flexibilty and openess to accommodate various work settings, locations and interactions/collaborations with different colleagues. Experienced UIR Engineer with BSc degree in relevant Technical Field (Electrical Technology, Mechatronics, Mechanical Engineering, etc.) or equivalent experience. Experienced in technical industry is required and/or semiconductor industry experience prefered. Experience in using computer applications, including data analysis tools, spreadsheet, and presentation software. Responsibilities Problem analysis and approachGather all information relevant for the problem, analyze using available means, gather additional diagnostic info if needed, decide on initial approach to solve problem and execute, consult with others. Problem handovers and routingHandover problem or problem aspects to others (2nd line support), document and package all data relevant for problem resolution (e.g. pass-downs, work orders, field service reports, system problem reports, technical reports). InstallationInstall equipment at customers locations, including equipment with new features, unload components, inspect for damage, assemble, align and test. UpgradeExecute hardware installation and perform system setup/recovery for upgrade packages as well as support locally owned field swaps by working according to an up-to-date plan and following the sequence. Provide feedback during execution in order to improve cycle time and performance. ProceduresBased on arranged customer machine time window to arrange for all (possible) parts, tools, equipment and information / knowledge to be available at start of procedure, execute procedure. Process OptimizationSignal gaps and improvement opportunities and reports it to the relevant stakeholders Training / adviceExplain appropriate actions to users to correct malfunctions, train customers in use and routine maintenance of equipment, recommend changes in user procedures when needed. Knowledge build-up and transferMaintain and broaden own knowledge, shares best known methods within the work group. CoachingProvide appropriate support and assistance to less experienced engineers on first tasks. This position requires access to controlled technology, as defined in the United States Export Administration Regulations (15 C.F.R. § 730, et seq.). Qualified candidates must be legally authorized to access such controlled technology prior to beginning work. Business demands may require ASML to proceed with candidates who are immediately eligible to access controlled technology. Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

1. 植牙產品及相關牙科產品銷售、行銷。 2. 既有客戶維護及陌生開發潛在客戶，拓展市場達到業績目標。 3. 公司提供完整系統性的教育制度，並有輔導員進行輔導訓練。 4. 參與產品推廣活動(如專業課程、展會)。 5. 無經驗可，具牙科相關背景尤佳。 7. 歡迎個性開朗、積極、親切，具業務開發能力者佳。

＃想跟著新創公司一起學習、成長嗎？ ＃歡迎熱情的您，加入我們的行列！ 【工作內容】 1. 執行新產品機構設計及開發。 2. 規劃產品製程及功能驗收測試。 3. 量產產品改善及優化。 4. 與醫院/學校合作研發專案。 5. 醫材法規評估。 ＃有醫材品質系統或法規經驗尤佳。

1. 產品資料蒐集及分析、技術諮詢、文件支援 2. 有能力組織、進行教育訓練、發表會及seminar 3. 計劃書撰寫、協作能力 4. 協助處理專案相關作業 5. 其它交辦事項

職務內容: 1.測試規劃與設計 1)協助研發團隊制定模組及系統驗證計畫。 2)根據產品規格和法規要求，設計驗證與測試方案。 3)協助工程師評估實驗設備、治具及測試環境需求。 2.模組及系統組裝與驗證 1)依據設計文件完成模組及系統組裝。 2)執行功能測試、性能驗證及可靠度測試。 3)記錄測試數據，進行初步分析並提出改善建議。 3.協助工程師Debug與問題分析 1)協助研發及韌體/軟體工程師進行系統問題排查。 2)記錄異常現象及重現流程，提供Debug支援。 3)協助改善產品設計及測試流程。 4.技轉與產線導入 1)協助將研發完成產品技轉至量產。 2)協助產線撰寫標準作業流程(SOP)。 5.測試驗證計畫與報告 1)依據法規需求撰寫測試驗證計畫 2)整理測試結果並撰寫測試驗證報告 3)確保驗證流程符合ISO 13485及相關醫療法規要求。

1.負責新產品製程開發、設計 2.與合作廠商共同進行模具開發、試驗和改善工作 3.製程文件撰寫 4.廠內生產模治具開發、設計 5.主管交辦事項

This vacancy is open for talent pool collection. We will contact you if we have proper vacancies that fit with your profile. Job Mission Represent manufacturing and act as gatekeeper from manufacturing to D&E function Add value in overall manufacturing processes such as forming, machining, joining, and assembling Job Description Contribute to the solution of faults and takes the necessary initiatives and practical decisions to ensure zero repeat Identify gaps and drive assigned process improvement projects and successful delivery Initiate and drive new procedure changes and projects Develop and maintain networks across several functional stakeholders Prioritize works and projects based on business situation Transfer knowledge and train colleagues on existing and newly introduced products Education Master degree in technical domain (e.g. electrical engineering, mechanical engineering, mechatronics) Experience 3-5 years working experience in design engineering Personal skills Show responsibility for the result of work Show proactive attitude and willing to take initiative Drive for continuous improvement Able to think outside of standard processes Able to work independently Able to co-work with different functional stakeholders Able to demonstrate leadership skills Able to work in a multi-disciplinary team within a high tech(proto) environment Able to think and act within general policies across department levels Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

1.Review customer specifications and establish corresponding inspection methods as operating procedures. 2. Issue Certificates of Analysis (COA) to customers. 3. Approve inspection data to ensure compliance with quality spec/standards. 4. Plan and execute Measurement System Analysis (MSA) and Gauge R&R studies. 5. Coordinate with inspection teams and cross-functional departments to ensure smooth quality operations, and drive continuous improvement. 6.Carry out duties and responsibilities as assigned by the supervisor.

1. SolidWorks 2D/3D圖面繪製 2. 協助處理研發相關工作 3. 主管交辦事項

亮宙科技致力於醫療器材的研發設計，在此領域擁有豐富的專業背景。現階段，公司正在積極發展，並期待找到對醫療科技充滿熱情、渴望與我們一同成長的夥伴。 期待你擁有專業技能和良好團隊合作精神，這份工作將會參與醫療雷射設備的開發，並負責以下工作內容： 1. 醫療雷射設備之開發。 2. 機構設計、製圖及測試。 3. 協助有關ISO文件製作與維護。 4. 其他主管交辦事項。 如若對醫療器材產業不熟悉也沒關係，我們更看重你的專業技能與發展潛力，如果你對這個職位感興趣，歡迎主動與我們聯繫。

【職責關鍵任務】 1. 執行蛋白質及胜肽純化分離工作 2. 執行動物及植物蛋白萃取 3. 負責撰寫實驗方法SOP及文案 4. 負責開發研發提案 5. 具HPLC、FPLC分析及分離經驗 地點：屏東縣長治鄉。 【大江生醫 8436 的優勢】 擁有優秀的研發團隊，先進領先的研發製程、科學化成分效果驗證更與全球學術界接軌，常態交流功能性食品與護膚品領域的創新研究，設置醫藥等級的品質管控實驗室，以有效用的產品以及高價值成本，為品牌客戶創造競爭優勢。 TCI 榮獲2019天下雜誌2000大調查經營績效50強第5名為前10名內唯一生物科技企業這份榜單綜合2016-2018過去三年營收、獲利及股東權益統計分析，代表2018年展現強大營運爆發力的公司! 【完整的訓練藍圖】 提供100小時以上的業務訓練課程，安排專業師資親自授課，協助新人快速步入職場軌道，同時結合線上學習平台，課程內容包含：產品行銷技巧、專案流程、產品介紹(保健品與保養品)、包裝包材課程、成本報價課程、簡報提案技巧、期刊論文剖析、儀態課程、美妝課程、營養知識、多元數位工具教學、名人知識論壇等超多元課程。 【榮耀舞台】 在職期間表現優異，有機會參加大江之星選拔，成為大江之星還有機會獲得豐厚獎金或出國旅遊等機會。 【TCI 能帶給你未來藍圖】 TCI 科研實力、博士團隊助攻、結合國際趨勢，整合生物科技調配高效配方，這個職位，您能和世界級一流的品牌客戶對接、幫客戶設計並打造出世界級的產品。 每季績效考核，全球輪調訓練，與公司創造雙贏機會，只要你敢衝敢拼，都有機會晉升主管， 百萬年薪只是起點! 除了業務在前線努力衝鋒外，產品設計師亦有機會參與國際展會，到全球各地的戰場開拓國際視野，成為最佳的助攻手!

1. Prepare and Submit Regulatory Documentation: Compile, review, and submit high-quality regulatory applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Application (ANDA), and Marketing Authorization Applications (MAA), to regulatory authorities. 2. Liaise with Regulatory Authorities: Act as the primary point of contact with regulatory agencies, responding to inquiries, providing additional data, negotiating requirements, and facilitating timely approvals or resolutions. 3. Monitor and Interpret Regulatory Changes: Continuously track updates in pharmaceutical regulations, policies, and industry trends, interpreting their impact and advising internal stakeholders (e.g., R&D, legal, and marketing teams) on necessary adjustments. 4. Ensure Product Compliance: Review and approve product labeling, packaging, advertising, and promotional materials to ensure alignment with regulatory requirements, including safety, efficacy, and legal standards. 5. Manage Regulatory Submissions Timeline: Oversee the preparation and submission process to meet deadlines, ensuring all documentation is accurate, complete, and submitted in accordance with agency specifications. 6. Maintain Regulatory Records: Organize, update, and archive regulatory documentation, correspondence, and approvals in a systematic manner to support audits, inspections, and future submissions. 7. Conduct Regulatory Risk Assessments: Identify potential regulatory risks or roadblocks in product development or marketing, proposing mitigation strategies to ensure compliance and project success. 8. Handle Post-Marketing Changes: Prepare and submit regulatory applications for post-marketing changes, such as updates to manufacturing processes, labeling revisions, or formulation changes, ensuring timely approval and compliance with regulatory standards.

1. 主導高階技術研究與創新，保持技術領先 2. 開發數位化檢測與分析服務，如自動化數據分析、AI 風味識別 3. 推動數位化工具落地，提升檢測流程效率 4. 帶領技術團隊，提升技術能力 5. 確保技術方案符合市場需求

1、協助研究員執行專案內容之實驗操作(微生物培養、檢驗分析、培養基及配方調配) 2、協助處理實驗專案文書作業 3、其他主管交辦事項

1. 新產品設計及樣品輸出 2. 模檢治具評估與設計 3. FMEA建立及分析 4. 產品設計暨規格圖面輸出 5. 設計製造成本分析 6. 產品專利提案說明 7. 供應商協同開發 8. 品質異常分析改善 9. 其他主管交辦事項 ✨ 我們的特色 ﹫國際市場導向，與歐美客戶密切合作 ﹫優質的企業文化與舒適的工作環境 ﹫積極投入研發與商品化，打造台灣濾材的世界品牌 ﹫通過十餘項的國際認證，並設有自有實驗室 ﹫橋頭科學園區新總部建設中，預計 2027 年啟用 了解更多關於公司，請至 https://caware.co 或直接投遞履歷，我們會與您聯絡！

＊加入我們，成為食安與品質的專業守護者。 ＊在挑戰與學習中成長，實現食品安全專業價值。 【工作內容】 1.餐飲門市食安巡檢：定期進行門市食品安全與衛生檢查，確保前線營運符合標準。 2.工廠稽核與品質監督：監督工廠生產流程，執行稽核與檢驗，維持產品品質穩定。 3.供應商管理：供應商實地稽核，確保供應鏈的食安與品質符合公司要求。 4.異常與改善：針對異常與客訴進行原因分析，協助跨部門制定改善計畫並追蹤執行。 5.教育訓練推動：規劃與執行食品安全教育訓練，提升同仁食安意識與專業能力。 6.專案與支援：參與主管交辦的專案或臨時任務，累積跨部門協作與專案管理經驗。

您的工作內容 1.法規與註冊：主導醫療器械註冊與法規流程，協助公司完成國內外醫療器材查驗登記與維護，確保產品合法合規上市。 2.品質管理與認證：負責 ISO13485 體系、QMS、FDA、CE 等流程與申請，建立並持續優化品質管理系統。 3.國際認證協助：支援國內外醫療產品註冊與認證相關事宜，確保時效與進度符合市場策略。 4.專案與補助計畫：熟悉 SBIR 創新研發補助計畫、國家發展基金創業天使計畫、SIIR 服務業創新研發計畫者尤佳，可協助公司爭取資源。 5.跨部門協作：協助主管交辦的專案與策略工作，提供法規與品質顧問建議。 6.加分條件：有內視鏡相關產品註冊經驗或辦理過衛署/FDA/CE 等醫療儀器證照尤佳。 我們期待的您 7.熟悉醫療法規、產品註冊、品質管理系統或專案管理，有實戰經驗或強烈學習意願。 8.細心、負責任、擅長分析與整合資料，能與跨部門協調合作。 9.對醫療科技與國際市場有熱情，願意不斷成長與精進。 我們提供的發展與回饋 10.國際視野：接觸全球醫療法規與市場，累積國際醫療產業人脈與專業。 11.專業成長：從法規到品質，再到專案與研發，有完整職涯發展機會。 12.穩健保障：所有相關規定依《勞基法》遵守，提供正規福利與職涯支持。 13.影響力：本職位是公司重要的法規與品質顧問，對公司運營與未來發展至關重要。 為什麼加入我們？ 挑戰性與成就感兼具：你將扮演跨國醫療器材事業的關鍵推手。 成長空間大：不僅限於法規與品質，更有機會參與研發與專案管理。 有意義的工作：你的努力將直接影響醫療品質、病患安全與國際市場拓展。 如果您具備企圖心與專業精神，想挑戰一份能真正累積國際醫療人脈與專業的工作，立即投遞履歷，與我們一起創造醫療科技的未來！

1.品質管理系統維護、文件處理、審查、改善、內外部稽核。 2.生產批次紀錄彙整和審查，客訴報告回覆。 3.主管交辦事項。

1. 協助研究計畫執行、電腦蒐集資料、數據分析及研究相關作業。 2. 閱覽英文病歷、跨部門溝通聯絡 3. 研究計畫報告撰寫及相關作業。 4. 其他臨時交辦事項。

1.螺絲規範~檢查、測試、或測量材料、產品、裝置，使之符合規格。 2.使用測量儀器（如：游標卡尺或千分尺、硬度機、膜厚機、鹽霧機等）測量產品的尺寸以符合規格。 3.分析及解釋圖面、數據、螺絲規範(DIN、IFI)手冊和其他材料，以確定規格、檢驗程序、測試程序、調整方法、檢定方法等。 4.收集或挑選樣本，以進行測試或作為模型使用。 5.分析、計算測驗數據，以確認測試結果。