瑞健股份有限公司

【關於瑞健】 SHL Medical是設計、開發和製造先進自體注射裝置的全球領導者。我們在全球擁有6,000名員工，並與製藥和生物技術公司合作，提供創新的自動注射器、筆型注射器和其他藥物傳輸系統開發與製造，以確保患者獲得有效的治療。自2018年起，SHL的總部正式設立於瑞士，並在瑞典、台灣和美國設有主要營運據點，共同致力於創新、影響力和成長。我們開發能夠為數百萬患者的生活帶來有意義改變的解決方案，同時我們也致力於營造一個支持、包容和充滿活力的工作場所。 【工作內容】 • 數量的盤點、記帳 • 零件的收料、備料以及拉料 (油壓車) • 使用物流系統投入生產工單所需要的所有物料。 • 生產事情作業排成 • 協助物料專員執行盤點作業活動 • 完成主管交辦有關生產產品、程序事宜 【人才需求】 • 一年以上製造行業工作經驗佳 • 12小時，4休3制（早班 0800-2000 / 夜班2000-0800 / 輪班 2-3月輪一次） • 數字觀念清楚、細心度佳 • 視力及辨色力正常（裸視 0.6以上 / 矯正後視力 0.8以上） *薪資不含津貼與獎金，加班另計* 津貼/獎金/加班費 發放方式依公司規定辦理

【工作內容】 • 進行製造現場的產品組裝、檢驗、包裝出貨等作業（大約5-10公斤） • 填寫生產報表，以檢視與生產目標的距離 • 完成主管交辦有關生產產品、程序事宜 【人才需求】 • 12小時，4休3制（日班 0800-2000 / 夜班2000-0800） (兩種班制選擇: 固定日班或是輪班，二到三個月輪一次） • 數字觀念清楚、細心度佳 • 視力及辨色力正常（裸視 0.6以上 / 矯正後視力 0.8以上）

Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請： https://www.shl-medical.com/careers/jobs-at-shl-medical/it-services-engineer 【Job Overview】 SHL Medical 正在尋找一名資訊工程師加入資訊台灣資訊團隊。資訊工程師的職責包括管理和維護 Microsoft Windows 客戶端基礎設施。此職位需與終端用戶、供應商、IT、安全部門以及業務相關方密切合作。資訊工程師將與業務用戶和系統擁有者共同計劃、提案並提供符合技術最佳實踐和公司業務目標的客戶端技術解決方案。 【Main Responsibilities】 1. Service Delivery and Process Adherence 服務交付和流程遵循 ‧ Strictly adhere to all applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs) ‧ Implement and maintain IT Service Management (ITSM) best practices and Good Manufacturing Practices (GMP) ‧ 確實遵守所有適用的標準作業程序(SOP)和工作說明書(WI) ‧ 落實並執行IT服務管理(ITSM)最佳實務做法和優良製造規範(GMP) 2. Incident Management and Service Request Fulfillment事件管理和服務請求履行 ‧ Serve as the primary point of contact for the Servics, handling all incidents and service requests across the organization. ‧ Provide comprehensive IT support through multiple channels (phone, ITSM portal, walk-in) ‧ Deliver remote troubleshooting and phone-based technical consultation services ‧ Manage tickets in the ITSM system according to defined Service Level Agreements (SLAs) ‧ Assess the nature, impact, and urgency of incidents, escalating to Level 2 (L2), Level 3 (L3) support, or Subject Matter Experts (SMEs) when necessary ‧ Investigate user requirements, collaborating with L2/L3 engineers and SMEs to ensure needs are met ‧ 擔任 IT Services 第一線窗口，負責接收和處理所有事件(Incident)和服務需求(Service Request) ‧ 透過多元管道(電話、ITSM系統、現場支援)提供全方位的IT支援服務 ‧ 提供遠端故障排除和電話技術諮詢服務 ‧ 依據服務等級協議(SLA)在ITSM系統中管理工單(Ticket) ‧ 評估事件的性質、影響範圍和急迫性，必要時將問題向上升級(Escalate)至二線(L2)、三線(L3)支援或專業技術人員(SME) ‧ 調查使用者需求，與L2/L3工程師和SME合作，確保需求獲得滿足 3. Knowledge Management and Continuous Improvement知識管理和持續改進 ‧ Collaborate with SMEs to develop and update the First Level Resolution (FLR) knowledge base ‧ Strive to improve First Contact Resolution (FCR) rate and optimize problem-solving efficiency ‧ 與SME合作開發和更新第一線解決方案(FLR)知識庫 ‧ 致力提高首次聯繫解決率(FCR)，提升問題解決效率 4. IT Asset Management IT資產管理 ‧ Establish and update standards for IT equipment allocation ‧ Maintain accuracy of asset status within the ITSM system ‧ Assign IT assets based on user requirements and Work Instruction ‧ 制定和更新使用者資產使用與配發標準 ‧ 維護ITSM系統中資產狀態的正確性 ‧ 依據使用者需求和內部標準分配IT資產 5. System Maintenance and Updates系統維護和更新 ‧ Execute routine updates and maintenance for endpoints according to schedules and plans ‧ 按計畫執行終端設備(Endpoint)的例行更新和維護 【Required Skills & Qualifications】 ‧ Knowledge in Windows client performance analysis, including use of performance monitor or related tools to identify bottlenecks or resource issues ‧ A high level of autonomy in combination with a results-driven mindset ‧ Not afraid to speak English, and willing to work in a foreign company environment. ‧ 了解Windows客戶端性能分析，包括使用性能監控器或相關工具識別瓶頸或資源問題 ‧ 具有高度的自主性，並具有以結果為導向的心態 ‧ 不害怕說英文，願意在外商環境中工作

1. 門禁管制及車輛進出指揮。 2. 訪客進出登記及換證。 3. 訪客拜訪通知相關單位及引導。 4. 注意公司門面確保乾淨整潔。 5. 廠區巡視維護廠區安全。 6. 夜間監看監視器畫面留意可疑及回報。 7. 確保廠區安全公共安全，避免火災、竊盜及其他危害。 8. 其他臨時主管交辦事項。

1.廠區清潔維護、備品補充。 　　 2.清潔機具設備操作。 3.依據公司管理系統、規範、班表，執行清潔作業。 4.VIP室暨公寓清潔維護。 5.其他主管交待工作事項。 6.須配合，隔周六加班

****【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】：https://www.shl-medical.com/careers/jobs/ci-continuous-improvement-engineer Job Overview The role will work with different business functions within the organization to improve manufacturing and operations processes using lean methodology concepts and other improvement tools. Lead and support CI programs and lean transformation to promote lean culture & work safety, improve quality & efficiency, and achieve a world-class lean manufacturing facility. The role must also help to identify & analyze improvement opportunities to have a clear visibility of benefits that will rationalize the management approval and execution. The role may also require leading, managing, and/or supporting medium-scale cross-functional projects that are align to site goals, operational excellence initiatives, and best practices. Educate and train employees to effectively use the CI tools to support company growth, scale-up, and achieve the business goal. This also includes facilitation of some CI related activities and workshops. Responsibilities: • Facilitate and drives Continuous Improvement program to promote lean culture. • Coach and mentor Lean Champions to become an independent driver and promoter of continuous improvement of their department. • Spearheads cost-saving initiative’s justification in line with identified Lean/CI projects. • Supports the achievement of set performance objectives (KPIs) for the workstream. Proposes action plans in collaboration with the Lean Champion. • Focuses on business performance that constantly strives to eliminate waste & improve customer satisfaction with lean tools and methodologies. • Conduct process analysis and being able to simulate or build models of processes, carrying out VSM (Value Stream Mapping) and guide the implementation of e.g., SMED, Visual management, Kanban/Pull system, Kaizen, 6S, routine Gemba Walk, etc. • Train and educate employees with Lean tools and techniques in line with the CI training program to be able to promote Lean culture. • Transform company culture with a strong focus on lean processes and best 6S practices. • Responsible for planning and assisting in the execution of various Lean/CI activities aimed at improving the business’s performance on safety, quality, delivery, and cost. • Adheres to established Quality Policy, GMP, and EHS rules. • Promotes SHL culture strategies and values. • Undertakes other duties as appropriate within his/her competence, as required by superior from time to time. Qualifications: • Graduate of Degree in Industrial Engineering or related field or equivalent experience. • Minimum of 5-year experience in a lean or high-volume manufacturing facility as Process / Industrial / Lean/CI Engineer. • Analytical and capable of performing analysis for any type of information/data using descriptive and enumerative statistical methods • Ability to utilize Lean and/or Continuous improvement tools to generate meaningful and quantified improvement • Proficient in the use of computer programs such as office applications and statistical analysis software e.g., PowerPoint, Excel, Word, Minitab, etc. • Good command in English communication skills, both in speaking and writing; and experienced on technical report writing. Technical Skills: Lean Six Sigma Methodology, Project Management, Process Improvement, Change Management, Technical Writing, Training/Workshop Facilitation, MS Office Applications (Excel, Word, PowerPoint)

*薪資未含輪班津貼、加班費與獎金* 【關於瑞健】 SHL Medical是設計、開發和製造先進自體注射裝置的全球領導者。我們在全球擁有6,000名員工，並與製藥和生物技術公司合作，提供創新的自動注射器、筆型注射器和其他藥物傳輸系統開發與製造，以確保患者獲得有效的治療。自2018年起，SHL的總部正式設立於瑞士，並在瑞典、台灣和美國設有主要營運據點，共同致力於創新、影響力和成長。我們開發能夠為數百萬患者的生活帶來有意義改變的解決方案，同時我們也致力於營造一個支持、包容和充滿活力的工作場所。 【職缺簡介】 MFMP的生產模式為自動化組裝，主要將前段的塑件及鐵件進行自動化的組裝，組裝的成品可區分為上本體、下本體 【工作內容】 • 設備巡檢、保養、異常排除、故障檢修及品質確認 • 監控產線整體設備效率(OEE)、產出、不良率與參數設定 • 主導產線機台每日點檢項目 • 參與機台與製程提升與改善活動 • 完成主管交辦有關生產產品、程序事宜 【人才需求】 • 12小時，4休3制（早班 0800-2000 / 夜班2000-0800） • 須配合輪班（2至3個月輪一次） • 具有機台維修組裝經驗者佳 • 具有自動組裝機經驗尤佳 • 視力及辨色力正常（裸視 0.6以上 / 矯正後視力 0.8以上）

【Job Overview】 The objective of the AMSD CE engineer is to develop automation system in medical industrial. The building process follows GAMP5 and includes of URS review, create design spec, code building and system integration test. Except PC/PLC control engineering and programming skill, we shall always keep win-win attitude and have efficient communication with team and make sure to success together. 【Main Responsibilities】 1. Develop control software for automation machines. 2. Create design documents, including Software Design Specification (SDS), Hardware Design Specification (HDS), and Schematic Drawing Designs (ELS). 3. Lead software design review meetings for the operations team and customers. 4. Develop integration testing protocols and complete system integration. 5. Maintain machine software for local and overseas sites (EU and US). 6. Provide customer support, including troubleshooting and answering technical questions. 【Required Skills & Qualifications】 1. 3+ years of experience in automation and software development. 2. Familiar in PLC programming and using structured text is a plus. 3. Good in English writing and reading (TOEIC grade 400+).

【在醫療器材產業中，品質絕對是擺在第一位！】 我們的客訴團隊不是單純接電話接收客人的負面情緒，而是接收到客訴案件後展開調查、分析及實驗，並將整個過程產出報告回覆讓客人知道，若你想要了解到瑞健多樣產品的話這會是一個很好的機會 (若您想要了解的是一個產品的完整製造流程，可以參考QA - Quality Engineer (Product) )！ SHL Medical AG is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018. 【Job Overview】 The responsible area includes complaint handling process with customers, root cause investigation for product quality complaint, regulatory concern in critical quality event, post-market data analysis, and quality system activities. This position works closely with internal and external stakeholders to identify/ drive improvement initiatives in whole product lifecycle and quality management system so to ensure continuous product safety and effectiveness on the market. 負責與客戶的客訴處理流程、產品質量投訴的根本原因調查、重大質量事件中的法規考量、市場後數據分析以及品質系統活動。此職位需與內部及外部相關方密切合作，識別並推動整個產品生命周期和品質管理系統的改進措施，以確保產品在市場上的持續安全性和有效性。 【Main Responsibilities】 ‧ Serve as company liaison with foreign customers and deliver outstanding customer service to resolve product quality complaints ‧ Analyze complaint failure modes according to complaint descriptions, evaluation on returned defect samples, manufacturing records, and design history records ‧ Complete technical investigation and root cause analysis with cross functional team members ‧ Issue corrective and preventive action (CAPA) and verify the effectiveness of CAPA ‧ Compose and submit a detailed and high quality report for the root cause investigation ‧ Ability to effectively communicate and interact with foreign customers, team members, and various technical disciplines covering end-to-end product lifecycle (e.g. mechanical design, injection molding, plastics, metal, assembly, functional testing) ‧ Periodically complaint data analysis to identify actionable insights and continuous improvement for product/ process, and present complaint statistics to customers and management. ‧ Establish and maintain complaint investigation method and provide training to customer’s complaint handling center when required. ‧作為公司與外國客戶的聯絡人，提供卓越的客戶服務來解決產品客訴 ‧根據投訴描述、退回的缺陷樣品評估、製造記錄和設計歷史記錄分析投訴失效模式，與跨功能團隊成員完成技術調查和根本原因分析 ‧發佈糾正和預防措施（CAPA）並驗證其有效性 ‧撰寫並提交詳細且高質量的根本原因（RCA）調查報告 ‧能夠有效地與外國客戶、團隊成員和涵蓋端到端產品生命周期的各種技術領域進行溝通和互動（如機械設計、注塑成型、塑料、金屬、裝配、功能測試） ‧定期進行投訴數據分析，以識別可行的洞察和產品/流程的持續改進，並向客戶和管理層展示投訴統計數據 ‧建立和維護投訴調查方法，並在需要時為客戶的投訴處理中心提供培訓 【Required Skills & Qualifications】 ‧Bachelor or above degree in science or engineering background (e.g., mechanical, industrial engineering, biomedical, chemical engineering, material/life science) ‧Logical thinking and proficient problem-solving skills ‧Fluent English in speaking and writing with strong organizational and communication skills ‧Ability as a team player to frequently cooperate with cross-function team members in different ways (e.g., phone call/meeting/e-mail) ‧Time management ability to complete assigned jobs in a timely manner ‧Good flexibility/anti-stress ability to deal with different/urgent issues ‧理工科或工程學相關背景的學士或以上學位（如機械、工業工程、生物醫學、化學工程、材料/生命科學） ‧邏輯思維和熟練的問題解決能力 ‧流利的英語口語和寫作能力，並具有較強的組織和溝通能力 ‧作為團隊成員，能夠經常以不同方式（如電話會議、面談、電子郵件）與跨功能團隊成員合作 ‧時間管理能力，能夠及時完成分配的工作 ‧良好的靈活性和抗壓能力，能夠處理不同/緊急問題

● 操作與維護生產設備，並確保其功能能夠正常生產 ● 負責並參與設備、生產技術及流程改善 ● 主管交辦事項

***【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】*** https://www.shl-medical.com/careers/jobs-at-shl-medical/mfps-software-engineer 【Job Overview】 The Software Engineer will be an integral member of the team driving the technical advancement of the Manufacturing Execution System, which is part of SHL's digitalization journey. This role involves planning, assessing, proposing, and implementing solutions that fulfill business requirements in the MES system. The Software Engineer will oversee the design, implementation, testing, and deployment of manufacturing process solutions, supporting business departments in improving operational performance and capability in our manufacturing facilities worldwide. This position offers an excellent opportunity for professionals who are eager to participate in digital transformation and play a technical leadership role in the manufacturing domain. 【Main Responsibilities】 (1) Align requirements with software and systems capabilities and provide feasible solutions to business owners. (2) Plan, design, and implement manufacturing solution integrations according to industry best practices to improve the company's Overall Equipment Effectiveness (OEE). (3) Develop and execute test cases, scripts, and protocols that sufficiently document alignment between design, implementation, and business requirements. (4) Assist users in the correct use and consultation of responsible manufacturing software systems.

Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請： https://www.shl-medical.com/careers/jobs/it-services-tech-lead *此職缺非管理職，歡迎有使用SCCM/Intune管理和監控端點設備經驗者投遞* 【Job Overview】 In Taiwan, SHL Medical is looking for a Client Engineering Tech Lead as part of the Information Communication Technology Service team. The responsibility of the Tech Lead comprises the management and maintenance of Microsoft Windows client infrastructure. 【Responsibilities】 ‧ Operational end point device delivery and management. ‧ Successful conduct Win11 rollout, deploy WI and lead L1/L2 members to achieve project milestone. ‧ Properly plan aged device replacement and endpoint device procurement plan. ‧ Properly plan and implement latest stable versions of global standard software applications as well as patching/update. ‧ Effectively manage and monitor endpoint devices using SCCM/Intune, including MFA, software, policy, and patch deployments, as well as BYOD management. ‧ Well manage vendor and our internal supply chain communication. ‧ Up-To-Date maintenance of both H/W and S/W, including optimization plan delivery. ‧ Assist or design global client engineering process as well as optimization plan delivery. ‧ Properly perform knowledge management with documentation and workshop. ‧ Properly conduct ITSM ticket process. ‧ Update/rectify resolution for each ticket, especially from technical point of view. ‧ Comply with SLA regulation as P1/P2/P3/P4 priority. ‧ Work closely together with the Information Security organisation to enhance and improve security setups for client infrastructures. ‧ Strong organisational qualities to meet tight deadlines as well as coordinate, prioritise and communicate project status to all applicable parties. ‧ Help to grow a healthy, collaborative engineering culture in line with the company values. ‧ Serve as an Individual Contributor. ‧ Engage in bilingual communication on a daily basis. ‧ 端點設備的操作交付與管理。 ‧ 妥善管理供應商和內部供應鏈的溝通。 ‧ 保持最新的硬體與軟體維護，包括優化計劃的交付。 ‧ 協助或設計全球客戶工程流程及優化計劃的交付。 ‧ 妥善進行知識管理，包括文件編寫和工作坊。 ‧ 妥善執行 ITSM 工單流程。 ‧ 與資訊安全組織密切合作，增強和改進客戶基礎設施的安全設置。 ‧ 具備強大的組織能力，能夠在緊迫的期限內完成工作，並協調、優先處理和傳達專案狀‧態給相關各方。 ‧ 幫助培養符合公司價值觀的健康、協作的工程文化。 ‧ 擔任個別貢獻者的角色。 ‧ 在日常工作中進行雙語溝通。 【Qualification】 ‧ Bachelor's degree, ideally in Computer Science or Information Systems. ‧ 5+ Years of IT related experience in the following technologies: ‧ Microsoft Active Directory with Microsoft Entra ID hybrid-join enviornment. ‧ Microsoft SCCM/Intune, manage/deploy for large number of client devices (More than 5K). ‧ Microsoft Windows clients (7, 10, 11), use performance monitor or related tools to identify bottlenecks or resource issues, and analyze system performance accordingly. ‧ CLI or PowerShell scripts in automating operational processes. ‧ Meeting room technologies (SIP, projectors, TV, wireless presentation, AV, VC, room reservation terminal…etc.). ‧ Knowledge in Dell Technology, especially for Windows client configuration. ‧ Knowledge in MFP management as well as printing resolution. ‧ Microsoft 365 certified: Administrator Expert is preferred. ‧ Cisco Networking certificate is a plus. ‧ Good verbal and written communication in both English and Chinese are mandatory. ‧ Excellent communicator in a cross-functional team. ‧ A high level of autonomy in combination with a results-driven mindset. ‧ 大學學位以上，理想是資訊相關科系。 ‧ 超過5年的IT相關經驗，涵蓋以下技術： ‧ 會議室技術（SIP、投影機、電視、無線演示、AV、視頻會議、會議室預訂終端等）。 ‧ 熟悉Dell技術，特別是Windows客戶端配置。 ‧ 了解多功能複合機（MFP）管理以及打印問題的解決。 ‧ 擁有Microsoft 365認證：管理員專家優先考慮。 ‧ 具備Cisco網絡認證者尤佳。 ‧ 必須具備良好的中英文口語和書面溝通能力。 ‧ 在跨功能團隊中是出色的溝通者。 ‧ 具有高度自主性並具備結果導向的思維。

保障年薪14個月，到職即享有10天特休(年度在職比例給予天數) 上班時間: 7:00~16:00 無空班 1. 處理烹飪前與烹飪中之準備工作。 2. 廚房清潔工作。 3. 其它主管交辦事項。

1.年度清潔工作評估、規劃及管理。 2.廠區內外責任區、停車場及員工宿舍之環境整潔管理。 3.清潔機工具設備、清潔耗材採購及庫儲管理。 4.專責病媒防治管理。 5.專責汙水清運作業。 6.各類清潔養護教育訓練暨實作要領。 7.執行排班業務。 8.委外承攬作業規劃、管理及品質提升。 9.內外部稽核作業前置準備及配合稽核作業。 10.落實各項業務品質檢查並詳實記錄管理及歸檔。 11.有效激勵團隊士氣，建立維持正向積極工作態度。

【關於瑞健】 瑞健股份有限公司(SHL Medical)為領航全球的藥物輸送解決方案供應商，最主要的產品為自動注射器及筆型注射器。台灣為瑞健最大的營運據點，共三個廠區坐落於桃園。瑞健提供客人一條龍式的服務，包含設計、研發、驗證、確校、量產及組裝，客戶來自全球排名前25的大藥廠。職缺簡介 【職缺簡介】 設備工程師/技術師將依據公司發展策略，針對生產設備維護保養計畫執行保養管制作業和設備異常狀態排除、異常分析與追蹤處理，以減少異常狀態發生頻率，並執行設備、生產及流程改善計畫，使改善計畫得順利完成，以提升設備生產效能並確保設備運作正常。 【工作職掌】 ●生產設備維修 ●生產設備定期保養 ●自動化設備維修保養 【招募廠區】 ● 六福廠 - 桃園市蘆竹區六福路36號 ● 桃園廠- 桃園市桃園區國聖二街136號

【Job Overview】 As a Senior Automation Engineer, you will take on a role similar to a Technical PM. Your key responsibilities will include leading projects focused on the implementation of automated machines for assembly, packaging, and other fully automated processes across SHL's manufacturing plants worldwide. 【Main Responsibilities】 1. Project Management : • Responsible for the industrialization of fully automated assembly equipment for auto-injector, or assembly lines of semi-automatic assembly equipment • Lead and manage automation projects from concept through to implementation, ensuring alignment with project timelines and budget. • Develop detailed project plans, including resource allocation, milestones, and risk management strategies. • Coordinate with cross-functional teams to ensure smooth project execution. 2. Technical Leadership : • Oversee the design and development of automated assembly equipment for auto-injectors. • Provide technical expertise and guidance to both internal teams and external automation integration partners. • Ensure that all automated systems meet stringent quality and regulatory standards. 3. Process : • Work closely with automation integration companies to specify requirements, review designs, and validate performance. • Specify, Review design, verify and test equipment, and transfer automation equipment to Manufacturing that meets or exceed expectations in terms of lead-time, compliance, quality, performance, yield, availability and output. • Collaborate with internal quality and validation teams to ensure that all processes comply with quality standards and regulatory requirements. • Facilitate effective communication between internal departments and external partners to resolve technical issues and optimize system performance. • Collaborate with the Validation team and conduct equipment qualification and validation. • Work together with Suppliers, the Manufacturing Department and the Validation Department to maintain and improve general specifications and workflows. • Support and provide historical data to the Process Team to identify what assembly steps needs to be de-risked/tested in the lab. • Translate the process defined by the Process Team into requirement specifications for Suppliers (e.g. stop on force/distance, center part on dimension X) • Translate risk analysis into requirement specifications 4. Process Optimization : • Identify opportunities for process improvements and implement best practices in automation. • Conduct thorough testing and validation of automated systems to ensure optimal performance and reliability. • Monitor system performance post-implementation and make necessary adjustments to enhance efficiency. • Do root cause investigation for technical issues 5. Documentation and Compliance : • Maintain comprehensive documentation for all phases of the project, including design specifications, testing protocols, and validation reports. Responsibility include but not limited to: user requirement, engineering report, factor and site inspection protocol and reports, work instruction, time lines and project status updates,etc • Ensure that all project activities comply with company policies, industry standards, and regulatory requirements. • Prepare and present regular project updates to senior management and other stakeholders. 6. Training and Support : • Provide training and support to manufacturing and maintenance teams on new automated systems. • Develop training materials and standard operating procedures (SOPs) for automated equipment. • Offer ongoing technical support to resolve any issues that arise during production. • Transfer knowledge to the Manufacturing Department

****【Kindly submit your application directly through our company website. 請直接透過我們的公司網站提交您的申請】：https://www.shl-medical.com/careers/jobs/oe-6-month-internship-program DISCLAIMER: This internship program requires 6 months of full-time commitment, starting anytime between March 2025 to July 2025. 【Company Introduction】 SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment. 【Job Overview】 We are looking for 8-10 interns to join the Operation Engineering (OE) department, which focuses on mass production engineering across automation, packaging, printing, metal forming, and injection molding. Every team member plays a crucial role in ensuring excellence and quality in our processes. Our diverse team, representing 15+ nationalities, works collaboratively to drive innovation in automation, packaging, forming, and plastic injection molding. 【Open Internship Positions 】Opportunities are available in the following four teams under OE department: 1. Molding Technology 2. Automation Technology 3. Packaging, Printing & Metal Forming Technology 4. Factory Projects 【Application Requirements (All documents must be in English) 】 1. CV 2. Cover Letter: Please indicate your interest in a specific team. 3. University Transcript 【Working Location】Taiwan – SHL LF site 【Qualification】 。Student in Engineering, Applied Sciences or other equivalent education 。Independent thinker who is willing to discover new solutions off the beaten tracks 。Interest in advanced high-volume production technologies, process improvement and medical manufacturing 。Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Polymer Science, Plastics Engineering, Injection Molding / Tooling Technology, Product Development, Process Development 。Strong intercultural and interdisciplinary communication skills in English (spoken/written) 。Diligent, reliable and target oriented team player 。For Factory project position: - Previous experience / training in Project and/or Operations Management - Knowledge of common collaboration and productivity tools in MS O365 - Interest in Project Analytics, Continuous Improvement, Operations Management

【Job Overview】 As a Senior Automation Systems Engineer, this role is designed to lead integration of automated machinery into SHL IT and manufacturing operation systems to execute the development, implementation, and qualification of data handling systems for automated equipment. You will work closely with external vendors and SHL IT teams, ensuring seamless integration from development to qualification. This role also requires expertise in Data base, Networks, MES, ERP, Windows domain integration, and cybersecurity to support scalable and secure automation processes. 【Main Responsibilities】 （１） Data Handling System Development: • Define user requirements for data handling systems for fully automated machines, covering production operational requirements (e.g., regular checks, HMI, user management, equipment modes, feeding/unloading systems), quality control (QC sampling, production reporting, OEE), and IT/OT system integration in compliance with GAMP 5. • Collaborate with external vendors and internal IT teams to develop, test, integrate, and qualify systems. • System Integration and Network Management • Integrate equipment into the SHL network, ensuring seamless data exchange with MES, ERP, and Windows domain environments. Develop secure data exchange strategies using OPC UA for IT and OT system integration. • Communicate and collaborate with vendors to align on network architectures, including Layer 2/Layer 3 designs, VLAN segmentation, and subnet planning, ensuring compatibility with SHL’s IT infrastructure. • Develop network infrastructure stategies for IT and OT systems, including switches, routers, firewalls, and industrial Ethernet devices such as PROFINET and EtherNet/IP. • Troubleshoot network-related issues during machine development, qualification, and operational phases to minimize downtime and maintain system reliability. （２）Regulatory and Compliance: • Ensure compliance with 21 CFR Part 11, including electronic record management, audit trail, and user permissions. （３）System Qualification: • Lead the integration and qualification of new automated equipment with existing IT/OT systems, ensuring regulatory compliance and seamless operations. • Develop and execute validation protocols aligned with 21 CFR Part 11. Assist in Documentation completion and review including and not limited (internal guide line and rules, URSs (User Requirement Specification), SDS (Software Design Specification), FAT, SAT) （４）Cybersecurity and Compliance: • Work closely with the IT team to implement cybersecurity measures, protecting both IT and OT data integrity. • Maintain compliance with 21 CFR Part 11 and other relevant standards. （５）Continuous Improvement • Optimize data handling and system integration through data analysis, performance monitoring, and upgrades. • Develop automation tools and algorithms for real-time data analysis and system optimization. • Collaborate with cross-functional teams to improve both mechanical and control aspects of automated equipment. • Documentation and Reporting • Maintain detailed and accurate documentation for IT/OT integrations, cybersecurity measures, and compliance activities. • Develop and update Guidelines, Work Instructions (WIs), and Standard 　Operating Procedures (SOPs) to standardize IT/OT processes and ensure consistent implementation. • Facilitate regular reviews and updates of documentation to reflect changes in processes, technologies, and compliance standards.

【About SHL Medical】 SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues. 【Job Overview】 The Head of Development Emerging Technologies (DET) Taiwan is responsible for developing medical devices (electromechanical and others) according to the SHL product roadmap and in compliance with SHL’s quality processes. The Head of DET TW ensures that the necessary capabilities and capacities to develop the products are available. 【Main Responsibilities】 • Act as a contract technology developer for technologies adjacent to the core business for internal and external customers end-to-end, from ideation until commercial release. • Define and align the scope, specifications and content of product releases, set timelines for those releases, and manage the design, development, verification and validation efforts to those timelines. • Build and maintain a high performing development team (with a focus on electromechanical medical devices), foster team collaboration and establish a culture of creativity, efficiency and effectiveness. • Develop an organization structure that is optimized to deliver product releases according to project plan(s). Periodically review and reorganize teams to address capabilities and gaps as required to deliver on business priorities. • Set base for complete in-house development of medical devices and their successful approval under CE and FDA, including the necessary QMS processes • Develop and foster a network of partners (suppliers, universities, etc.) to efficiently develop the products. • Provide cross functional leadership to define and execute the product roadmap. Share technical, procedural, and business knowledge with others. Frequently communicate progress on the product roadmap and milestone commitments throughout the team and organization – drive visible results. • Support the commercial organization in promoting the products at their stage of development with customers and in the market. 【Minimum Qualifications】 • Master degree or PhD in Engineering, preferably Electronics, Mechanics or related field. • 5+ years work experience in a similar role, ideally in the regulated medical device market. • Strong experience in highly regulated industry, ideally healthcare sector, specifically in drug delivery. • Have a track record of moving “from the lab to the market” or translating new technology into commercial products •• Enterpreuneurial spirit to launch novel products •• Experience in supporting pre-sales, sales and post-sales activities with customers • Strong communication and influencing skills, ability to convince others • Ability to prioritize, multi task and to work well in high-pressure environment. • Proven track record in building, managing and mentoring engineering teams. • Experience to develop according to medical device standards • Experience developing according to the V-model; PMP or PRINCE certification a plus 【Language skills】 • Fluent English is required. • Mandarin or another language is a plus.

【在醫療器材產業中，品質絕對是擺在第一位！】 SHL Medical 不斷地在擴編，QA - Engineer 需要更多新血的加入，目前有大約100位品保工程師及專員一起位品質做把關，我們是以「專案」進行分工，你將在這個專案中成為QA的代表，因此會了解整個產品的製造流程，但若您想要了解的是多種產品，可以參考QA - Customer Quality Engineer (Complaint Team) )！ 【Main Responsibilities】 ‧ Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team. ‧ Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement. ‧ Complete the evaluation and detailed investigation on the observed nonconformities during manufacturing process. ‧ Present accumulated quality data to customers and management. ‧ Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues. ‧ Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines. ‧ Support external quality inspections and execute internal and supplier audits. ‧ Complete assigned tasks on time with minimal supervision (self-motivated). ‧ 領導/參與與專案相關的品質活動，並向團隊提供品質建議。 ‧ 必須展現以客戶為導向的態度，跨部門合作技巧以及良好的品質判斷能力。 ‧ 在製造過程中對觀察到的不符合項目進行評估和詳細調查。 ‧ 向客戶和管理層呈現累積的品質數據。 ‧ 利用統計和品質改進工具識別品質數據的趨勢，以預防品質問題再犯。 ‧ 能有效地與外國客戶（歐美及日韓地區居多）、團隊成員和各種技術專業互動和溝通。 ‧ 支援外部品質檢查並執行內部和供應商審核。 ‧ 能在時間內主動積極的完成被分配的任務 【Required Skills & Qualifications】 ‧ BS degree above or equivalent technical work experience. ‧ Clear / logical thinking with strong organization and communication skills ‧ Proficient problem solving skills. ‧ Working knowledge of Microsoft Office. ‧ Experience in the medical device industry is preferred. ‧ Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred. ‧ CQT (certified quality technician), CQE (certified quality engineer) is a plus. ‧ Six sigma green belt or black belt is a plus. ‧ 工程學士學位以上或品質/製成相關工作經驗。 ‧ 具有清晰/邏輯思維和良好的組織和溝通能力。 ‧ 熟練的解決問題能力。 ‧ 熟悉Microsoft Office軟體。 ‧ 具有醫療器械行業經驗者優先考慮。 ‧ 熟悉法規合規要求：GMP、QSR、和ISO 13485者優先考慮。 ‧ 持有CQT（認證品質技術員）、CQE（認證品質工程師）證書者優先加分。 ‧ 擁有六標準差綠帶或黑帶證書者優先加分。