1.新產品開發及設計實務經驗 2.產品優化及測試驗證 3.作業標準制定與製程選用 4.搜尋市場新趨勢，導入於產品上 5.具Solidworks基本繪圖能力(必要)，面試時需實務測試輕型機車,普通重機車

1. 負責模具機構評估、開發設計、驗證測試與維護解決模具相關問題。 2. 熟悉模具設計，且有模具評估和試模的經驗。 3. 與國內外客戶端檢討模具設計、與廠商溝通模型製作、開模、試模，並檢討修改模具。 4. 計劃執行進度控管。 5. 跨部門溝通協調、解決產品開發、試產相關問題。 6. 負責生產製程的規劃與安排及產品工程技術文件之製作。 7. 建立及改善各項產品製程技術。 8.主管交辦事項。

協助醫療器材研發工程 醫療器材新產品開發及改良 開發驗証作業評估及執行 產品量產及導入工廠計畫 規劃排程，評估人力、設備和原物料需求 負責專利申請作業 協助新產品或新功能的開發專案、支援設計工作

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自然科學學門,工程學門

1.新產品創意構思及提案，與工業設計師研究設計是否可行 2.規劃零件組成方式，使其符合工業設計師所設計的模型 3.設計模具， 結構設計，使產品能夠量產機械工程學類,電機工程學類,其他工程學類普通小型車,普通重機車

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. Job Overview This position is for a senior technical role in Project Engineering Dept. in Taiwan. You will lead and be accountable for the Engineering activities related to the development of medical drug delivery systems. Main Responsibilities - Lead and develop a technical team of experts to support the industrialization of our autoinjectors - Lead and manage the Subject Matter Experts (SME) from different fields related to tooling, injection molding, spring manufacturing, metal parts processing and assembly automation. - Understand current practices and develop new or improved processes and methodologies based on in-depth processing experience. - Promote use of new technologies and industry-leading trends. Provide the highest level of technical expertise. - Lead Root Cause Analysis (RCA) using problem-solving methods and tools. - 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 in collaboration with our Technology Transfer team. - Lead Design for Manufacturing & Assembly (DFMA) activities and define the manufacturing requirements for new products and product care initiatives. - Mentor our future generation of engineers and serve as a Subject Matter Expert (SME) in engineering. Skills and Qualification - Degree in Mechanical Engineering, Polymer Science or similar education/experience. - Minimum 6 years of relevant industry experience with hands-on experience with injection molding systems and/or automation equipment. - Deep understanding of medical device development operations, with experience in leading technical projects e.g., cost savings initiatives or new supplier introductions. - 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 on problem-solving and Root Cause Analysis (RCA) methodologies, six sigma certification a plus. - 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 an “own it” and “can do” attitude, team player and taking responsibility to get the job done. - Able to professionally communicate with stakeholders, upper management, and external parties. - Resilient and able to work under pressure. - Pragmatic and data-driven mind. - 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) (TOEIC 750 and above).工程學門

【About Us】 SHL Medical 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. Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the 【Job Overview】 The TEST Industrialization and Method Maintenance (TEST-IND) department is a global team and a branch within the Global Testing and Simulation Organization. TEST-IND are responsible to acquire test equipment’s to meet the needs of new products as well as industrialize laboratory test methods into automated solutions for both engineering and mass production environment. Our team are also building up the “center of competences” together with global members in Testing & Simulation to increase knowledge sharing and strengthen our core competences. 【Main Responsibilities】 • Establish end-to-end test solutions, from identification of requirements to implementation of test equipment’s • Drive cross-department projects for new test solutions or continuous improvement of existing test solutions • Communicate and collaborate with global team members, test equipment vendors and customers • Conduct technical activities including design review, engineering studies, test method development and validation • Perform problem solving and root-cause-investigation, including collaboration with designers, simulation, and statisticians • Build up the center of competencies from testing technologies, and create guidance for knowledge sharing • Actively participate in standardization and process improvement activities • Opportunity to work globally at the oversea sites of SHL Medical, including the US, Switzerland and Sweden office 【Required Skills & Qualifications】 • Bachelor’s degree in Mechanical Engineering or similar, ideally combined with 1-3 years of work experiences • In-depth knowledge of mechanical design and passion for testing technology • Skilled in structured problem solving, analytical and logical thinking • Strong organizational and project management skills • High level of independence, positive and curious attitude • Familiar with 3D design software (SolidWorks or other CAD) and technical drawings • Proficient in English (TOEIC 700 or above) • Project management skills to lead projects according to timelines機械工程學類

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 since late 2018, with sites in Sweden, Taiwan, and the Unites States. This role is embedded in the Packaging and Forming Technology Group within our Global Operations Engineering team in Taiwan. Possible location for this position: Taiwan You are · 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, Engineering components (springs, screws, etc.), Metal cold forming processes, Chemical cleaning processes · Strong intercultural and interdisciplinary communication skills in English (spoken/written) · Diligent, reliable and target oriented team player We offer · A variety of challenging internship opportunities across multiple products and disciplines within our Global Operations Engineering Team · The opportunity to solve real-world problems in a growing, future-proof industry · Competitive compensation, Labor and group insurance · Local HR support (Relocation and Accommodation as applicable) · Dedicated on-site senior mentor guidance · Asia-experience in a highly innovative, international company · Flexible work-from-home policy · Start date: flexible upon agreement機械工程學類,資訊工程學類,工業工程學類

1.醫療器材新產品開發、量產改良 2.3D、2D設計繪圖及檢討修改 3.新產品功能驗證 4.產品認證文件製作、維護 5.具備齒輪設計相關經驗 6.熟悉機械加工製程 7.機構設計相關工作經驗二年以上機械工程學類

1.製作QC表 2.繪製工件及醫療品相關等圖面(2D&3Ｄ) 3.主管交辦事項 4.具Solidworks基本繪圖能力(必要)，面試時需實務測試普通小型車,普通重機車

1. 具2~3年生產設備工程師經驗 2. 有射出機/自動化機台開發及操作經驗 3. 諳模具/懂模具維護保養 4. 機台維修，故障排除/問題分析改善/參數驗證確效等 5. 諳撰寫生產設備操作/保養SOP 尤佳 6. 須懂繪制工程圖面 7. 熟量測儀器操作者 8. 協助製程效率改善者，製作生產治工具 9.承接RD技轉，並可教育訓練作業人員操作機台輕型機車,普通小型車

1.機械設備維修經驗 2.設備維修能力，可分析與改善設備穩定度 3.機台操作及例行性機台清機保養 4.有電路的基本了解 新人培訓期為月薪28000，通過考核後即調整為月薪30000起，依能力調整

1.產品結構設計 2.零件制式圖面繪製 3.開發試做、設計變更作業 4.零部件目錄編制作業 5.量產前技術指導 6.技術資料作成 7.產品認證作業CE、FDA 8.能獨立作業。 #持有iPAS證書者可優先面試 (工具機機械設計工程師)工程學門,工業技藝及機械學門輕型機車,普通小型車

1. 流體控制相關之機構設計 2. 光學檢測系統架構整合設計 3. 配合於五股工業區或新竹科學園區辦公地點上班 4. 此為代普銳奇公司(泰博科技關係企業)代徵之職位機械工程學類,電機工程學類,電子工程學類普通小型車