01. 門禁管制及車輛進出指揮。 02. 訪客進出登記及換證。 03. 訪客拜訪通知相關單位及引導。 04. 注意公司門面確保乾淨整潔。 05. 廠區巡視維護廠區安全。 06. 夜間監看監視器畫面留意可疑及回報。 07. 確保廠區安全公共安全,避免火災、竊盜及其他危害。 08. 其他臨時主管交辦事項。
QE team expand in 2023! We‘re lookng for the experienced partner working together! Job Overview The Quality Engineer is responsible for supporting new product development, process development and product care through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product/process inception through product launch, scale-up and maintenance and play an active role in the processes to ensure products meet quality standards consistent with Customer Requirement, while meeting all design control and other regulatory requirements, including, but not limited to FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 11608 & ISO 14971 Main Responsibilities • Team member representing Quality on new product/process development and product care projects. • Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements. • Assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – UFMEA, DFMEA, PFMEA. • Develop quality plans and work further with Manufacturing on the transfer of quality requirements. • Promotes the use of statistics in the testing and control of quality. • Supports Device product/process development and production activities, including the following: - Develops or reviews product/process verifications/validation or test plans (protocols and reports). - Develops or reviews product/process specifications and requirements. - Develops or reviews product reliability specifications/predictions, reliability test activities. - Participates in risk management activities including review failure mode effects analysis (FMEA), hazard analysis, - fault tree analysis (FTA) and/or risk or statistical analysis. - Participates in product or process design and change activities, including design reviews. - Provides technical support for product quality attributes/decisions. - Support selected verification/validation activities (e.g., toxicology/biocompatibility, sterilization validation, etc.)with external suppliers. • Contributes to compilation and maintenance of Design History Files (DHF). • Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System Required Skills & Qualifications • Education:Technical / scientific degree at college / university level (mechanical, industrial, biomedical, chemical engineering, material/life science) Experience_Occupational experience • At least five years’ work experience in a Product Development/Design Assurance function in regulated environment (medical devices/Diagnostic instrumentation industry, pharmaceutical or biotechnology industry.) • Experience in the design and development of products in accordance with ISO 13485 guidelines. • In depth know-how and experience of quality techniques: Six Sigma Blackbelt, Six Sigma methods such as DFSS, DMAIC, DoE, FMEA, etc. • Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testings • Experience in the entire Design life-cycle and Phase-Gate development process. Experience_Special knowledge, expertise, experience • cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC • Statistical methods • SAP (Manufacturing Execution Systems / MES will be an advantage) • English (spoken and written), local language (Mandarin) is a plus
SHL Medical is the 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, SHL has sites in Sweden, Taiwan, and the Unites States. Job Overview The role requires application of engineering knowledge and ingenuity to deliver risk analysis related to medical device manufacturing processes using tools such as - Failure Mode and Effect Analysis (FMEA). The candidate will work with cross-functional teams to ensure processes development, control planning and qualification of manufacturing processes are aligned with risk-based approach and meets ISO 14971:2019 requirements. Main Responsibilities • Develop Assembly Risk Assessment document from Assembly Guidance of product to ensure control plan and process development are done according to product risk levels • Participate in process and equipment design review activities and conduct comprehensive Failure Mode and Effect Analysis (FMEA) of manufacturing processes and related equipment to ensure risk exposure to product and end used is reduced as far as possible at design stage. • Attend relevant project meetings to ensure all information required to develop, update, and maintain risk management documents for related projects are captured and utilized effectively. • Participate in relevant product lifecycle management activities to provide/collect information and ensure FMEAs are updated accordingly – e.g., NCMR & complaints, CCB meetings, MPQ meetings, deviations meeting etc. • Ensure periodic review and update of FMEAs according to comply with procedural and compliance requirements. • Cascade information and actively participate to propose risk control methods in control planning, process development and equipment development stages through use of ARA and FMEA. • Where needed, participate and contribute on end-to-end processes risk management in SHL including material handling, transportation, packaging, sterility and testing of final combination product. • Organize cross-functional meetings with project team members to communicate all open items from FMEA reports and derive solutions to mitigate the risks. This includes active engagement with AMSD and external equipment suppliers where needed. • Escalate potential issues and progress blockers on risk management work to team leaders and ensuring resolution is achieved with minimal impact to project timeline. Skills and Qualification •Masters in Life Science Engineering discipline (or) Degree with 2 years of work experience. Exposure to medical device, pharmaceutical or biotechnology industry is added advantage. • Trained on Quality System Regulation, Process Validation, Risk Management or Design Control course. • Demonstrated and applied a broad knowledge in quality management assignments and risk management approaches. • Good communication and interpersonal skills and demonstrate ability to participate in inter-departmental projects and resolve quality-related issues in a timely and effective manner. We Offer • An exciting opportunity in a fast-growing international medical device company • A modern working environment, with multicultural and dynamic teams • Flexible working hours and a hybrid remote work policy
請直接透過我們的公司網站提交您的申請: https://careers.shl-medical.com/job/MFMP-%E7%B5%84%E8%A3%9D%E6%8A%80%E8%A1%93%E5%B8%AB/571-zh_TW/ 【關於瑞健】 瑞健醫療 ( SHL Medical ) 為領航全球的藥物輸送解決方案供應商, 在設計、研發及製造先進藥物輸送系統上居龍頭地位, 產品含括自動注射器、筆型注射器與穿戴式藥物輸送系統等。 【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 ***薪資未含輪班津貼、加班費與獎金***
Job Overview : As a Usability Engineer (UX Researcher) in SHL Medical, you will be the voice for end users from initial to late product development stages for electronic and non-electronic medical devices. You will be responsible for planning, scoping, and implementing the suitable usability activities to ensure users’ perspectives are brought into product development and meeting authority requirements at the same time. In addition, work closely with cross functional teams internationally, including Sweden, US, and Taiwan, will be how your daily work is like. Seldom travel is expected in relation to executing usability tests. Main Responsibilities: 1. Prepare and carry out product-related Usability Engineering activities in all stages of the product development process – from initial ideas to the formative study. 2. Work in close collaboration with Market Analytics, Project and Product Managers, Industrial Design team, Project Teams (ME, EE, SW, FW, QA, RA, etc.), vendors, and our customers to fulfill the expectations and requirements timely. 3. Produce and compile Usability Engineering history files for internal and customer projects according to regulatory requirements and SHL’s QMS of electronic and non-electronic medical devices. 4. Be familiar with the authorities‘ regulations regarding the Usability Engineering requirements for products for self-injection and digital medical devices. 5. Implement and continuously improve SHL’s Usability Engineering Process globally. 6. Contribute to the continued development of the Industrial Design and Usability Engineering Team and competency area within SHL. Skills and Qualification: 1. BS or MS in human factors, ergonomics, cognitive psychology, behavioral science, human-computer interaction, informatic science, communication and technology or similar qualifications. 2. Experience in planning and conducting small to large-scale user and usability studies. 3. Understanding of product development and Industrial Design process and methods. 4. Open-minded, proactive, persistent, results- and execution-oriented, and able to work under pressure in changing environments. 5. Team player and self-starter, able to perform with minimal supervision and capable to engage with multiple disciplinary design teams. 6. Fluent English and Mandarin in speech and writing.
【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。 【部門簡介】 供應鏈部門主要由需求計畫、採購、物流、運務(船務)及情報五個團隊組成,通過建立健全的供應鏈來滿足客戶的需求,關注整個價值鏈中的客戶和供應商關係。 【工作內容】 1. 執行物料接收與理貨、物料拆箱與換箱、成品包裝與出貨等相關作業 2. 執行庫存盤點作業,確保物料收發作業與物料庫存系統單據文件一致 3. 執行SAP等系統作業 4. 遵循工作指導書與程序書等作業規範 5. 其他主管交辦事項 【人才需求】 1. 需著潔淨服執行拆料作業 2. 須配合輪班,上任初期為早班08:00~16:00及中班13:00~22:00(一~五)、後依作業調整轉為早班08:00~20:00或夜班20:00~08:00(做四休三,可固日或夜) 3. 具備辦公室軟體操作能力(word/excel) 4. 具備團隊合作精神、學習意願高 【聯絡資訊】 如欲應徵,請協助填寫以下連結資訊,我們將優先審核您的履歷,謝謝。 https://forms.office.com/r/B1zsmF04RR
【About Company】 SHL Medical is a global leader in designing, developing, and manufacturing advanced drug delivery systems. With over 5000 employees worldwide, we provide innovative devices like auto injectors and pen injectors to top pharmaceutical and biotech companies globally. Headquartered in Switzerland since late 2018. Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our diverse and ambitious team shares a common goal of delivering the right drug devices for modern precision medicine. 【Department Introduction】 The Supply Chain department at SHL Medical consists of five teams: demand planning, procurement, logistics, shipping, and intelligence. We build a strong supply chain that prioritizes customer and supplier relationships across the entire value chain to meet customer demands effectively. 【Job Overview】 As part of the Procurement team at SHL, your responsibilities will include supplier management, sourcing strategy, price negotiation, contract management, and purchase management. You will oversee both direct (raw materials) and indirect procurement categories. 【Main Responsibilities】 1. Direct Material Management: Oversee the procurement of direct materials, including resin, metal, and packaging. 採購範疇:負責原物料採購,包含塑膠原粒、金屬原料及包材。 2. Supplier Relationship Management: Manage and cultivate relationships with suppliers to ensure effective collaboration and partnership. 管理國內、外供應商。 3. Contract Negotiation: Negotiate with suppliers to secure favorable contract terms that align with organizational objectives. 與供應商協議採購之價格、折扣、出貨及付款等之最佳條件。 4. Contract Execution and Cost Savings: Implement and monitor agreed-upon contract terms with suppliers to achieve cost savings and optimize procurement outcomes. 根據合約執行採購條件以達成本效益。 5. Customer Requirement Alignment: Collaborate with other departments to align procurement activities with customer product requirements and ensure customer satisfaction. 與相關部門合作滿足客戶產品需求。 6. Sourcing Process Management: Lead the sourcing process for assigned commodities, including market analysis, supply strategy development, and supplier evaluation based on spend data analysis. 執行採購物件的市場資訊蒐集、供貨策略研究、供應商調查及歷史資料分析等採購流程。 7. Cross-Functional Collaboration: Collaborate with other departments to identify and implement improvement initiatives aimed at providing enhanced services across the organization. 根據改進的需求與其他部門合作,以提供更好的服務予整個集團。
SHL Medical is the 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, SHL has sites in Sweden, Taiwan, and the Unites States. Job Overview This role is embedded in the Packaging & Forming Technology Team within our Operations Engineering Department in Taiwan. Your responsibilities ● Together with the rest of your team you will support the production of packaging material and component printing processes for our autoinjector systems ● Lead engineering responsibility for packaging production lines and printing processes within our production system ● Collaborate closely with shop floor production technicians, maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future packaging and printing concepts ● Lead improvement initiatives and capacity deployment in packaging and printing ● Responsible for manufacturing acceptance of new packaging and printing processes in regular production ● Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products We offer - Competitive compensation package - Flexible hours and working from home policy. - Modern working environment with state-of-the-art facilities and technologies - Challenging assignments in a fast growing and innovative industry - Position in a dynamic, international team of highly skilled professionals - Various opportunities for personal and professional development within a global organization
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) We offer • Modern working environment with state-of-the-art facilities and technologies • Challenging assignments in a fast-growing and innovative industry • Position in a dynamic, international team of highly skilled professionals • Various opportunities for personal and professional development within a global organization
【Job Overview】 This role is embedded in the Molding Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Together with the rest of your team you will support the production of injection molded components for our autoinjector systems ● Lead engineering responsibility for molds, component manufacturing and corresponding processes within our production system ● Collaborate closely with shopfloor production technicians, tool makers and maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future mold generations and production setups ● Lead improvement initiatives and capacity deployment in injection molding ● Responsible for manufacturing acceptance of new molds in regular production ● Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products 【Your qualification】 ● Degree in Mechanical Engineering, Polymer Science or similar education/experience ● Minimum 5 years of relevant industry experience with hands-on experience with multi-cavity hot runner injection molding systems ● Thorough understanding of mold and machine setup, molding machine operation, process optimization, as well as mold design/function. ● Thorough understanding and excellent hands-on experience with auxiliary equipment (i.e. Hot runners, controllers, Polymer dryers, Thermolator, Mold heaters, robot/take out systems, etc.). ● Knowledge of engineering resin characteristics / validation of new polymer materials and molding processes for medical grade polymers. ● Statistical analysis knowledge, including an understanding of how to execute Design of Experiments (DOE). Six Sigma certification is a plus ● Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies ● Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) ● Ability to communicate in Mandarin is highly desirable 【We offer】 ● Competitive compensation package ● Flexible hours and working from home policy. ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization
【Job Overview】 This role is embedded in the Automation Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Improve system & equipment reliability for the core processes to meet all customer, business & regulatory requirements ● Together with the rest of your team you will support the production for automated assembly of our autoinjector systems ● Lead engineering responsibility for production/product lines and corresponding assembly processes within our production system ● Collaborate closely with shopfloor production technicians, equipment builders and maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future assembly lines and production setups ● Lead improvement initiatives and capacity deployment in device assembly ● Responsible for manufacturing acceptance of new assembly lines / processes in regular production ● Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products 【Your qualification】 ● Degree in Engineering or equivalent education/experience in a relevant field ● Several years of relevant hands-on manufacturing experience with highly automated high-volume production systems ● Hands-on experience with designing, developing and maintaining complex automated equipment is highly desirable ● Familiar with Siemens PLC based systems, sensor, actuator and vision technologies, SCADA ● Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams ● Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies; Six Sigma certification is a plus. ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost ● Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus ● Intercultural and interdisciplinary communication skills; able to communicate effectively in both Chinese and English (verbal, written) 【We offer】 ● Competitive compensation package ● Flexible hours and working from home policy. ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization
【Job Overview】 This role is embedded in the Packaging & Forming Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Together with the rest of your team you will support the production of packaging material and component printing processes for our autoinjector systems ● Lead engineering responsibility for packaging production lines and printing processes within our production system ● Collaborate closely with shopfloor production technicians, maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future packaging and printing concepts ● Lead improvement initiatives and capacity deployment in packaging and printing ● Responsible for manufacturing acceptance of new packaging and printing processes in regular production ● Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products 【Your qualification】 ● Degree in Engineering, Polymer Science or similar education/experience ● Several years of relevant experience in manufacturing of packaging components and/or printing technologies ● Expertise in one or more of the following: Vacuum / Thermo Forming (trays, blisters), Automated Printing Processes (e.g. laser/UV/Pad/Screen), Polymer Coating Processes, Packaging design and development ● Statistical analysis knowledge, including an understanding of how to execute Design of Experiments (DOE). Six Sigma certification is a plus. ● Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost ● Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) 【We offer】 ● Competitive compensation package ● Flexible hours and working from home policy. ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization
SHL Medical is the 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, SHL has sites in Sweden, Taiwan, and the Unites States. Job Overview This role is embedded in the Automation Technology Team within Operations Engineering Department in Taiwan. Your responsibilities ● Improve system & equipment reliability for the core processes to meet all customer, business & regulatory requirements ● Together with the rest of your team you will support the production for automated assembly of our autoinjector systems ● Lead engineering responsibility for production/product lines and corresponding assembly processes within our production system ● Collaborate closely with shopfloor production technicians, equipment builders and maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future assembly lines and production setups ● Lead improvement initiatives and capacity deployment in device assembly ● Responsible for manufacturing acceptance of new assembly lines / processes in regular production ● Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products Your qualification ● Degree in Engineering or equivalent education/experience in a relevant field ● Several years of relevant hands-on manufacturing experience with highly automated high-volume production systems ● Familiar with Siemens PLC based systems, sensor, actuator and vision technologies, SCADA ● Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams ● Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies; Six Sigma certification is a plus. ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost ● Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) We offer ● Flexible hours and working from home policy. ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization
【Job Overview】 This is a senior leadership role within our Global Operations Engineering team in Taiwan leading a large cross-functional program with high impact across the entire organization and providing progress reporting directly to executive management. 【Your responsibilities】 • Lead and direct large capital projects end to end through Ideation, Design, Execution and Assessment • Lead collaboration of the Engineering Group across other functional areas, establishing effective working relationships with all Business Partners. • Lead the Alignment of the Sponsor, Key Stakeholders, Core and Extended team to deliver the Final Project Objectives • Lead communication via Sponsor to Key Stakeholders on all aspects of projects and maintains strong internal project communications including presentations to Key Stakeholders • Lead project planning, execution, tracking and reporting against project Key Deliverables and Final Project Objectives. • Establish and maintain appropriate structures to ensure communication, flow of information and documentation within the project • Lead the selection of appropriate project functions and project resourcing and the development of strategies and Project Delivery Processes and tools • Lead risk management, evaluate, eliminate or mitigate risks to Final Project Objectives • Lead Coordination of the design, execution and close out of all project related activities including managing internal resources and the procurement of third-party contractors, suppliers and consultants and ensures the project remains on target: incl., but not limited to safety, scope management, contract and construction management, legal and corporate compliance, quality, project controls, commissioning, qualification and validation of FDA and other agencies regulated facilities, technology transfer and regulations governing product manufacturing • Lead Change Identification and request for changes, liaising with and informing the Sponsor, Core and Extended teams • Undertakes all Learning and Development to ensure Highly Capable Leadership, coaches and mentors others engaged in Project delivery 【Your qualification】 • Degree in Engineering or Applied Sciences • Minimum 10 years relevant industry experience in Operations, Product Development and/or Engineering • Project management and leadership experience in complex, large-scale CAPEX projects with numerous stakeholders and workstreams • Experience with corporate business transformation projects (product or process) • Proficient in state-of-the-art PM methodologies and tools • Experience in multiple areas: Production infrastructure and site development / Capacity scale-up / Logistics & supply chain management / Technology Transfer / Product & Platform development / Re-medication • Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is highly desirable • Lean / Six Sigma experience is highly desirable • Strong intercultural and interdisciplinary communication skills; excellent written and verbal English • Self-starter and fast learner, able to deal with ambiguity in a complex, dynamic and changing environment • Able to work under pressure to achieve short-term targets without compromising long-term objectives • Ability to communicate effectively in Mandarin is a plus 【We offer】 • Competitive compensation package • Flexible working hours • Modern working environment with state-of-the-art facilities and technologies • Challenging assignments in a fast growing and innovative industry • Position in a dynamic, international team of highly skilled professionals • Various opportunities for personal and professional development within a global organization
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems for the past 30 years 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 with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Factory Development & Projects group within our Global Operations Engineering team in Taiwan. Your responsibilities · Lead and manage challenging Industrialization, Infrastructure/Site development and technology transfer projects in Operations · Plan and manage production scale-up and capacity deployment projects as well as related product care initiatives in Operations · Develop concept studies and strategic decision proposals to senior management · Responsible for project planning, deliverables, schedule, cost and quality as well as management reporting · Establish and maintain appropriate structures to ensure communication, flow of information and documentation within the project · Cross-functional leader role interacting with senior management, various departments, internal stakeholders and clients · Ensuring effective change management and implementation of site infrastructure enabling fast and sustained ramp-up of production and benefit realization Your qualification · Degree in Engineering or Applied Sciences · Minimum 6 years relevant industry experience in Operations/Logistics, Manufacturing, Production Scale-up, Technology transfer or Facility/Construction management · Project management and leadership experience in highly complex projects with numerous stakeholders; proficient in state-of-the-art PM methodologies and tools · Experience in one or more of the following areas: manufacturing infrastructure and site development / intralogistics / supply chain management / contract manufacturing / technology transfer / injection molding, process automation · Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus · Lean / Six Sigma experience is a plus · Strong intercultural and interdisciplinary communication skills; excellent written and verbal English · Self-starter and fast learner, able to deal with ambiguity in a complex, dynamic and changing environment. · Able to work under pressure to achieve short-term targets without compromising long-term objectives We offer · Competitive compensation package · Flexible hours and working from home policy. · Modern working environment with state-of-the-art facilities and technologies · Challenging assignments in a fast growing and innovative industry · Position in a dynamic, international team of highly skilled professionals · Various opportunities for personal and professional development within a global organization
【Job Overview】 This role is embedded in the Factory Development & Projects Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Lead the development and implementation of factory and plant layouts together with our internal planning and SME teams and external contractors (architecture, design, planning, etc.) ● Ensure all stakeholder requirements are considered in the planning process and are translated into optimized factory designs, both from an Operational and Sustainability standpoint ● Review factory design and optimize site layouts for production, material flow, construction, and facilities. ● Convert identified potentials in production and logistics processes into a competent planning. ● Ensure compliance with relevant Codes, Standards and HSE requirements ● Ensure execution of standards, processes and procedures for effective delivery of operations excellence ● Work with manufacturing, logistics, facilities teams and contractors to ensure that equipment and layout designs align with the overall logistics and operational plans of for the factory ● Factory equipment and facilities: Develop equipment specifications and requirements based on product constraints / Provide design layouts and equipment solutions / Conduct equipment design reviews and provide design guidance to vendors. ● Support integration of systems and processes in to global digital landscape (EWM, EAM, MES,…) ● Provide technical leadership support to Project Managers to drive planning, implementation and project execution with the team ● Review and approval of critical layouts and facility specifications (space allocation, material flow, MEP, etc.) 【Your qualification】 ● Degree in Engineering, Construction, Production Management or other relevant discipline ● Minimum 10 years of relevant industry experience in Production Management, Operations/Logistics or Factory Planning/Design ● Hands-on production/logistics management experience in a high-volume, high-throughput production environment; Familiar with LEAN process optimization ● Proficient in layout design (preferably AutoCAD) and relevant drawing standards ● Knowledge of automated material handling / warehouse systems, production logistics, end of line installations, warehouse transportation and material flow optimization ● Knowledge of MEP and logistics requirements for large scale, high-volume production facilities ● Experience with ASRS (Automated Storage and Retrieval Systems) warehouse systems, AGV, conveyance, logistics, distribution, RFID and Material Flow Methods is highly desirable ● Experience with system integration to electronic warehouse and asset management systems(EWM/EAM) is highly desirable (preferably SAP) ● Experience designing greenfield facility layouts ● Project Management experience ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost ● Ability to assess and solve complex issues and tackle problems with limited initial information. ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) ● Ability to communicate efficiently in Mandarin 【We offer】 ● Competitive compensation package ● Flexible hours and working from home policy. ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization
【Job Overview】 This position is a senior technical role in the Molding Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Lead and develop a team of experts to support the production of injection molded components for our autoinjector systems ● Understand current practices and develop new or improved scientific molding processes and methodologies based on in-depth processing experience, plastics engineering fundamentals and materials science knowledge. Promote use of new technologies and industry-leading trends. Provide highest level of technical expertise ● Lead engineering accountability for molds, component manufacturing and corresponding processes within our production system ● Collaborate closely with Plant / Production manager, tool makers and maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future mold generations and production setups ● Lead improvement programs and capacity deployment in injection molding ● Accountable for manufacturing acceptance of new molds in regular production ● Lead Design For Manufacturing (DFM) and definition of manufacturing requirements for new products and product care initiatives ● Organize and lead plant level training activities to improve molding problem solving capabilities and process efficiencies 【Your qualification】 ● Degree in Mechanical Engineering, Polymer Science or similar education/experience ● Minimum 15 years of relevant industry experience with hands-on experience with multi-cavity hot runner injection molding systems ● Deep understanding of mold and machine setup, molding machine operation, process optimization, as well as mold design/function. ● Thorough understanding and excellent hands-on experience with auxiliary equipment (i.e. Hot runners, controllers, Polymer dryers, Thermolator, Mold heaters, robot/take out systems, etc.). ● Advanced knowledge of engineering resin characteristics / validation of new polymer materials and molding processes for medical grade polymers. ● Statistical analysis knowledge, including an understanding of Scientific molding processes, the mold- machine- material- process interactions, Design of Experiments (DoE) and mold qualification protocols ● Advanced knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies ● Proven track record in leading and developing a team of highly specialized experts; management experience ● Advanced knowledge in process development, verification and validation ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) ● Ability to communicate in Mandarin is highly desirable 【We offer】 ● Competitive compensation package ● Flexible hours and working from home policy. ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization
【Job Overview】 This role is embedded in the Automation Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 ● Lead and develop a team of experts to support the production in high-speed assembly and packaging of our autoinjector systems ● Understand current practices and develop new or improved assembly processes, automation solutions and automated inspection methodologies based on in-depth processing experience, automation engineering fundamentals and equipment design knowledge. ● Promote use of new technologies and industry-leading trends. Provide highest level of technical expertise ● Lead engineering accountability for automated assembly and test equipment, device assembly and corresponding processes within our production system ● Collaborate closely with Plant / Production manager, automation vendors and maintenance, quality and process development on performance/process improvements and trouble shooting ● Lead the development of improvement plans and requirements for capacity expansion and future equipment generations and production setups ● Lead improvement programs and capacity deployment in device assembly and packaging automation ● Accountable for manufacturing acceptance of new assembly and test equipment in regular production ● Lead Design For Manufacturing (DFM) and definition of manufacturing requirements for new products and product care initiatives ● Organize and lead plant level training activities to improve assembly / automation problem solving capabilities and process efficiencies 【Your qualification】 ● Degree in Mechanical Engineering, Automation or similar education/experience ● Minimum 15 years of relevant industry experience; hands-on experience with high-speed automated assembly of plastic and metal components ● Deep understanding of equipment design, process automation and relevant sub-systems (pneumatic/electric actuators, cam-driven pick and place systems, optical/capacitive/inductive and other sensor technologies, servo-driven systems) ● Experience with commissioning, qualification and validation of large automation equipment and processes ● Thorough understanding and hands-on experience with Siemens and/or Beckhoff PLC based systems, common sensor and actuator system, and vision technologies ● Hands-on experience in programming PLC/IPC and SCADA is highly preferred ● Advanced knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies ● Proven track record in leading and developing a team of highly specialized experts; management experience ● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done ● Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus ● Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) ● Ability to communicate in Mandarin is a plus 【We offer】 ● Competitive compensation package ● Flexible hours and working from home policy. ● Modern working environment with state-of-the-art facilities and technologies ● Challenging assignments in a fast growing and innovative industry ● Position in a dynamic, international team of highly skilled professionals ● Various opportunities for personal and professional development within a global organization
【About Company】 SHL Medical AG, headquartered in Switzerland, is a world-leading solution provider designing, developing, and manufacturing advanced drug delivery systems with over 5,000 employees worldwide. Our customers include top pharmaceutical and biotech companies around the globe that require innovative devices such as auto-injectors or pen injectors to deliver their drugs effectively. 【Job Overview】 In Taiwan, SHL Medical is looking for a Service Desk Engineer as part of the Information Communication Technology Service Desk team. The responsibility of the Service Desk Engineer comprises the management and maintenance of Microsoft Windows client infrastructure. The position cooperates closely with end users, vendors, IT, Security, and business stakeholders. Together with business users and system owners, the Service Desk Engineer plans, proposes, and provisions client technical solutions that meet technical best practices and the company’s business goals. This role requires an energetic and self-motivated individual with excellent communication and organisational skills to work cross-functionally. 【Main Responsibilities】 • Act as the first point of contact for users seeking technical assistance over the ITSM ticketing system, phone or email • Assist users on identifying issues and requests and maintaining the tickets in IT Service Management system within SLAs • Lead troubleshooting and root cause analysis to effectively resolve issues and deliver sustainable solutions in collaboration with technical peers • Monitor client infrastructure health and keep track of their availability, performance, and responsiveness • Support in evaluation and purchasing of IT hardware/software solutions • Perform IT assest management • 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 【Required Skills & Qualifications】 • Bachelor‘s degree, ideally in Computer Science or Information Systems • 1+ Years of IT related experience in the following technologies: o Microsoft Active Directory with Microsoft Azure Active Directory hybrid-join enviornment o Microsoft Windows clients (7, 10, 11) o Mutifunctional printers, office printers and label printers o Meeting room technologies (projector, TV, wireless presentation, AV, VC, room reservation terminal…etc) • Knowledge in Windows client performance analysis, including use of performance monitor or related tools to identify bottlenecks or resource issues • Knowledge of Windows networking technologies and use of diagnostic tools such as WireShark or Network Monitor to identify communication issues • Familiar with command lines or PowerShell scripts in automating operational processes • Computer certifications are a plus; especially Microsoft Windows or Cisco Networking • 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