瑞健股份有限公司

公司介紹

5000 人
桃園市蘆竹區六福路36號
聯絡人
人力資源部
電話
03-2170303分機7718
瑞健集團(SHL)成立於1989年,目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今,在全球製藥及生物科技領域,SHL已成為藥物輸送系統的OEM/ODM領導製造商,如自動安全注射器。除此之外,SHL還擴展許多產品線,像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等,目標市場為北美、歐洲及亞洲。 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.

相關連結

主要商品

1. 藥品注射器材 Drug Delivery Systems 2. 醫療科技及工業製造 Med-Tech & Industrial OEM Manufacturing 3. 醫院/家庭護理器材之設計製造 OEM/ODM Rehabilitation Equipment for home health care and hospital environment 4. 模具設計/製造 Tooling Design & Manufacturing

福利制度

1. 提供完善的薪資及福利制度(含三節、年終、績效獎金與員工酬勞等) Comprehensive salary and benefits 2. 年度員工健康檢查 Annual health check program 3. 員工團體保險(含意外險、防癌險、醫療險) Group insurance program 4. 優於勞基法特休天數Better package in annual leave with pay 5. 彈性工作時間 Flexible working hours 6. 生育、婚喪補助金、旅遊津貼 Subsidies of travel, birth, marriage and funeral grants etc. 7. 教育訓練(新進同仁訓練、OJT訓練、證照訓練、語文訓練、管理訓練等) Training programs (New employee orientation, OJT, licensing, language and management training etc.) 8. 多元開放的工作環境 Diverse and open working environment

工作機會

Operations PMO - [6 month internship] Analyst 瑞健股份有限公司
部分工時(月薪) NT$ 21,500+
桃園市蘆竹區
經歷不拘
Job Overview/Objective As an Intern under the Operations PMO, you will collaborate closely with global and local operations functions and support in resource planning, project status tracking and reporting. The role will involve working closely with global PMO functions and process management team to provide analytical support, maintain project templates and status to ensure that projects are running on time and within budget. This role is applicable to students wanting to collaborate on a Masters Thesis Project. Main Responsibilities 。Support in the development of standardized processes in the tracking and budgeting for capital expenses, cost estimation and operational efficiencies. 。Analyze the project performance, identifying potential risks or issues. 。Ensure that all project documentation is meticulously maintained, updated, and stored according to organizational standards. 。Support key project meetings, driving agendas, capturing minutes, and ensuring action items are assigned and tracked. 。Provide guidance of TimeSheet and project status updates to project team members Required Qualifications: 。Bachelor's degree in a related field (e.g., Business, Information Systems, Engineering). 。Outstanding communication skills with cross functions Personal Attributes: 。Analytical and strategic thinking capabilities. 。Self-motivated and proactive, with the capability to think ahead and anticipate problems, issues, and solutions.
全職
初階
10/20 更新
PDCP - Manufacturing Technology Engineer (Springs) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
2年以上
【Job Overview】 As a Manufacturing Technology Engineer (Springs) in our Component Process Development department (PDCP), you are responsible for the evaluation, development, implementation, and qualification of advanced manufacturing processes for our diverse spring component portfolio. The primary focus lies on the introduction of advanced, automated spring coiling and heat treatment equipment to support SHL’s transition to automated assembly processes. The objective of this role is to challenge the status quo, drive technology development, and establish optimized, robust manufacturing processes that balance high quality yields with optimal productivity to accommodate complex customer demands and enable future growth. Assuring successful project completion and process implementation within agreed time and cost constraints in close collaboration with interdisciplinary project stakeholder and assembly automation teams are key aspects of this role. 【Main Responsibilities】 • Own the development and implementation of novel spring manufacturing equipment linked to automated assembly lines for the production of medical devices • Innovate, co-develop, and optimize advanced mass production concepts with a primary focus on advanced spring production • Drive cross-departmental project activities together with our Project Management, Process Development, Supply Chain, Manufacturing, and Quality teams • Manage the relevant technical aspects of automation projects incl. systematic conduct of problem-solving activities, testing, and qualification tasks • Create the technical documentation, such as user requirements and machine specifications (URS), FAT/SAT protocols, and further reports for new production equipment • Safeguard all relevant specifications and ensure that they comply with regulatory requirements • Lead the installation and commissioning activities of new machines including FAT, SAT, and IOPQ • Act as a key point of contact for machine suppliers from Taiwan and Europe • Assess the technical feasibility of different solutions and advise key stakeholders on equipment sourcing strategies • Design and conduct experiments (e.g. laboratory or process experiments) in order to assess new technologies, materials, processes, equipment, etc. in terms of their suitability • Ensure cross-organization communication and act as an equipment information coordinator with a focus on technology transfer process to accommodate new production sites
全職
中高級
10/20 更新
QE - Program Manager (Platforms and Programs) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
8年以上
Job Overview The position of the QE Program Manager is responsible for leading programs and cross-functional teams through complex QE programs targeting in built predictability, efficiency, and compliance. Meanwhile, championing platform product development, process development, product care through the application of Quality Engineering skills. QE Program Manager manages activities, allocated resource capabilities, schedules, budgets and KPIs. Ensures companywide communication to facilitate on schedule, within budget successful activities completions. QE Program Manager works multi-disciplinarily, has innovative mindset, development skills with quality mindset, reduces risks and improves efficiencies from product/process inception through product launch, scale-up and maintenance to ensure products meet quality standards, customer requirements, spirit of design control process for medical devices. Main Responsibilities • Represents Quality Engineering Program Management in Product Lifecycle Teams • Plays an effective role as Quality Engineering PM in Product Lifecycle Management Team, including defining, developing, promoting design control, production/process control, and risk management processes that meets applicable regulatory (local and international), Corporate/Business, Customer, and Local QMS requirements. • Provides inputs and criticality/risk evaluation of quality, technical and regulatory requirements to Product Lifecycle Team • Identifies trends in product performance and systemic improvements. Allies with cross-functional team on the implementation plans • Interfaces with customers, suppliers, and various company departments to resolve quality problems and develop strategic quality improvement activities • Develops quality strategies and plans in support of execution of quality engineering program/business plans and meeting performance targets • Provides input for the development of company business and QMS processes to support growth • Continuously works to improve the efficiency of Product Development, Design Controls (Quality by Design), Risk Management, Control Planning processes to ensure the outcome satisfies both user expectations and business objectives • Provides quality technical management and leads performance improvements utilizing quality frameworks i.e., Early Quality Involvement and Design for Six Sigma (DFSS), Lean, Advanced Product Quality Planning (APQP), Variability identification and reduction in designs, processes, systems etc. • Responsible for organizing, analyzing, summarizing data and respective findings/conclusions • Establishes governance that promotes collaboration, prioritization, and control, identifies and request required support for QE Programs. • Regularly communicates the status of projects with stakeholders • Responds to the company needs, manages training programs Supports the development of training quality engineering, quality compliance, quality leadership talents with the right skills sets for programs supporting product life cycle management • Coaches SHL employees in application of LEAN, DFSS tools and techniques in projects (Green/Black Belt)
全職
經理/總監
英文 條件要求
10/20 更新
IT - Senior SAP Functional Engineer (FI Module) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
5年以上
[About the job] 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 delivery of modern precision medicine. [Main Accountabilities] 。Supporting finance daily operation within SAP including the closing activities on a global level 。Supporting enhancement/change request raised from business in SAP, be able to provide process solution to support the business need. Primary focus will be on SAP FI(AP/AR/GL/AA).Good to have CO knowledge and general knowledge of manufacture processor supply chain. 。Be the project manager of system enhancement/roll-out projects 。Be able to lead the solution/process discussion to ensure all solution design are well planned, project activities are well executed and managed 。Provide user training to users for those daily operation and new enhancement projects 。Provide sustainment support to other SAP modules based on needs 。Strong communication skill and be able to manage multiple projects and prioritize deliveries. 。Lead continuous improvement of AP processes [Required Knowledge and Skills] 。Excellent English / Mandarin 。Degree in accounting or applied economics 。Being able to read code / debug independently 。5+ years of experience in supporting SAP FI modules. Familiar with SAPFI system functionalities including GL/AP/AR/AA, and CO module 。SAP Certification is a plus 。Good to have general knowledge in manufacture process and supply chain process 。Good to have strong project management capability 。Good to have the experience in MNC and matrix environment 。Exposure to international working environment 。Deep understanding of OpenText Vendor Invoice Management (VIM) 。Customizing Financial accounting in SAP S4 。Good communicator 。Pro-Active personality 。Local team lead 。project management experience 。Data migration experience 。Experience working with CONCUR as an administrator
全職
經理/總監
英文 條件要求
10/20 更新
Testing - Design Verification Engineer 設計驗證工程師 瑞健股份有限公司
待遇面議
桃園市蘆竹區
經歷不拘
【Job Overview】 SHL Medical is looking for a talented Design Verification Engineer to develop the next generation of medical devices. This role offers a chance to make a difference in a company focused on engineering, working on products ranging from single-use auto-injectors to advanced drug delivery solutions. Our global team is dedicated to advancing medical technology and improving how patients receive their medications. At SHL Medical, our employees are passionate about medical and mechanical engineering. We strive to enable patient independence by allowing them to receive medications without needing to visit hospitals or clinics. 【What you’ll be doing...】 • Verify the design, materials, and components of medical devices for various product generations at both component and system levels. • Develop and integrate test plans and methods across different verification environments. • Create and validate test methods, including developing fixtures and writing validation reports. • Conduct studies on drug delivery systems to support worst-case test scenarios. • Help develop and test design prototypes. 【What we need to see...】 • Bachelor’s degree in engineering or a related science field. • Experience in designing fixtures and analyzing mechanical test setups. • Strong knowledge of mechanical validation testing and data collection. • Ability to automate mechanical tests. • Understanding of material failure analysis or data analysis. • Skills in statistical analysis. • Familiarity with industrial manufacturing processes. • Knowledge of Good Laboratory Practice (GLP) and Good Documentation Practices (GDP). 【Ways to stand out...】 • Hands-on experience in designing and testing mechanical products. • Proficiency in using mechanical engineering tools for test method development. • Strong problem-solving and analytical skills. • Excellent written and verbal communication in English. • Good interpersonal skills and a team-oriented mindset. With competitive salaries and great benefits, SHL Medical is considered one of the best employers in the world. We have some of the brightest and most talented people working with us. If you are creative, independent, and enjoy challenges, we want to hear from you. We are an equal opportunity employer and value diversity in our company. *** We welcome fresh graduates and will provide comprehensive training sessions. ***
全職
初階
英文 條件要求
10/20 更新
QE - Quality Engineer (Process - Molding&Tooling) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
2年以上
有別於常聽的到Quality Assurance(QA)和Quality Control(QC)是接近量產階段的部門,我們的Quality Engineering (QE)部門是屬於前端研發團隊中的一環。最重要的使命和任務就是,希望能大量減少產品走到量產的階段才發現問題來進行補救,而是在開發設計階段就針對品質去把關。 在醫療器材產業中,品質絕對是擺在第一位!目前部門擴大招募中,歡迎所有對於堅守產品品質有興趣的工程背景人選。 【Job Overview】 The Quality Engineer of Process - Molding&Tooling 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
全職
中高級
英文 條件要求
10/20 更新
QE - Quality Engineer (Process - Automation&Assembly) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
2年以上
有別於常聽的到Quality Assurance(QA)和Quality Control(QC)是接近量產階段的部門,我們的Quality Engineering (QE)部門是屬於前端研發團隊中的一環。最重要的使命和任務就是,希望能大量減少產品走到量產的階段才發現問題來進行補救,而是在開發設計階段就針對品質去把關。 在醫療器材產業中,品質絕對是擺在第一位!目前部門擴大招募中,歡迎所有對於堅守產品品質有興趣的工程背景人選。 【Job Overview】 The Quality Engineer of Process - Automation&Assembly is responsible for supporting new process development, automation equipment development and product transfer 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, deployment and retrofit, 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, 21 CFR Part11, ISO 13485, ISO 11608 & ISO 14971. 【Main Responsibilities】 • Represents Quality on process design, equipment development, and product transfer projects through Product Lifecycle. • Ensures that all design control and process/production control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements. • Assesses failure modes and approves the risk mitigation tool, techniques, good practices to ensure the risk management processes are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – DFMEA, PFMEA, and other risk assessment in system level. • Practices Quality Function Deployment (QFD) method to evaluate control action from Customer, Design, to Process-wise. • Promotes the use of statistics in the pre-study, engineering investigation, and in-process control based on quality aspects. • Supports Device product/process development and product transfer activities, including the following: • Consolidates or reviews lessons learned and historical data to influence product design. • Supports or reviews process/equipment specifications and requirements including system level. • Supports or reviews process/equipment verifications activity (protocols and reports) and validation/test plans. • Participates in product or process/equipment design and change activities, including qualification and reviews. • Participates in risk management activities including review failure mode effects analysis (FMEA) and/or risk or statistical analysis. • Provides technical support for product and process quality attributes/decisions. • Support selected qualification activities (e.g., advanced inspection performance check, 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.
全職
中高級
英文 條件要求
10/20 更新
PDMP - Molding Process Engineer (Plastic Component) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
3年以上
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5,000 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 United States. 【Job Overview】 The position as Molding Process engineer is to establish injection molding process development activities for New Injection molding project tools and to have repeatability process from development phase to series production. The responsibilities for this position, include but are not limited to, provide input on, DFMA, tooling and equipment development, collect scientific evidence to ensure the molding process are developed to achieve the customer specification, robust process and collaborate with cross-function team for troubleshooting. The current team consists of very experienced Engineers with a diverse area of expertise which will allow industry newcomers to be trained to become fully effective. 【Main Responsibilities】 .Contribute improvements for better manufacturability and economic to Design for Manufacturing before the tool has been ordered. .Kick off the tooling development and ensure the specification and the process has met demand of the project timeline. .Create and define specification of tool and plastic component itself .according to SOP’s timely to have measurable targets. .To initiate and facilitate the design review process and ensure specification are followed. .To define acceptance criteria not only for mould, but plastic components itself to ensure customer’s request are fulfilled. .Coordinate stakeholders within relevant departments. .To support engineering sample preparation. .Support manufacturing with occurring problems. .Responsible for communication internally and with internal stakeholders, design office, quality, supply chain, etc. .Initiate and facilitate trial shot activities, issue clarification & review/sign off related documents. .Assist for troubleshooting and root cause analysis once the component has some irregularities. .Decide on steel resizing of the tool according to the results of the development process. 【Required Skills & Qualifications】 .Familiar with plastic injection molding machine .Familiar with CAD model .Familiar with tool design/structure and manufacturing process. .Injection molding Knowledge must have. .Familiar with statistical analysis .Familiar with Plastic material and its application. .Excellent communication and coordinate ability. .Familiar about DFM process
全職
高級
英文 條件要求
10/20 更新
OE - Principal / Senior Manufacturing Engineer (Spring Technology) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
5年以上
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 Compression Springs for our autoinjector systems • Lead the Root Cause Analysis (RCA) investigations for non-conforming compression springs. • Familiar with spring winding processes (e.g., coiling, forming, bending, heat treatment, machine parameter set-up, etc.) with theoretical background and application experience to support RCA. • Collaborate closely with shopfloor production technicians, maintenance, quality and process development on performance/process improvements and troubleshooting. • Conduct risk assessment of the proposed process changes and suggest risk mitigation solutions. • Plan, communicate and implement Engineering Evaluation activities. • Document engineering requirements using the appropriate manufacturing document module. 【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
全職
經理/總監
英文 條件要求
10/20 更新
OE - Plant Simulation Engineer (Factory Planning) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
3年以上
【Job Overview】 This role is embedded in the Factory Development & Projects group within our Global Operations Engineering team in Taiwan. You will take a leading role in developing SHL’s simulation capabilities to support our global expansion and factory optimization strategies with advanced plant simulation models and process simulations. The role provides substantial growth potential and the opportunity to develop leading expertise in the field. 【Your responsibilities】 • Implementation of advanced, model-based factory planning and optimization processes in SHL’s Global Operation, Using a standardized, modular and reusable approach to simulation modelling. • Develop discrete event simulation models for various parts of the manufacturing and production line – Injection molding, Assembly, Packaging, Logistics, Material flow, etc. • Verifying and optimizing factory designs and capacities to support critical business decisions by using simulation and/or calculations. • Document and present simulation results to key stakeholders with a clear focus on assumptions, constraints, objectives and results based on empirical and statistical data • Develop a visualizations of high level factory operation and detailed subsystem operation to generate concise, clearly communicated analysis for stakeholders. • Improve the existing frameworks for knowledge management, model validation and development of inhouse simulation capabilities for factory planning and optimization. • Improve relevant procedures / processes and ensure adequate knowledge transfer/training within Operations. 【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
全職
高級
英文 條件要求
10/20 更新
OE - Project Engineer (Factory Automation & Equipment) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
3年以上
【Job Overview】 This role is embedded in the Factory Development & Projects Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 • Together with the rest of your team you will support the development, improvement and implementation of highly automated material handling and logistics systems • 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. • Improve systems & equipment reliability for the core processes to meet all customer, business & regulatory requirements • Collaborate closely with shopfloor production technicians, equipment builders and maintenance, quality and process development on performance/process improvements and troubleshooting. • Lead improvement initiatives and capacity deployment across multiple production processes. • Design review and optimization of site layouts for production, material flow, construction, and facilities. • Support integration of systems and processes into our global digital landscape (EWM, EAM, MES, …) 【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
全職
高級
英文 條件要求
10/20 更新
IT - (Senior) Data Engineer 瑞健股份有限公司
待遇面議
桃園市蘆竹區
5年以上
*** Welcome the expert in Microsoft Azure Cloud. If you're interested in this position, please email your English resume to HR Janet. (janet.huang@shl-medical.com) *** 【About Company】 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. 【Job Overview】 SHL Medical is seeking an experienced Cloud Data Engineer to join our Data & Analytics Competence Center. We has created our Data & Analytics Competence Center with the goal of unlocking SHL’s data potential for Business Success. Within this the department is providing services in BI, Analytics and big data across the whole organization. The team is a key driver for the transition to a data- and science-driven company. In this position, the Cloud Data Engineer can expect to work closely with experts from Data Engineering, Data Architecture and ICT colleagues in high impact projects that affect the entire organization. The candidate should be comfortable working with a wide range of stakeholders to drive the digital transformation and develop new digital services and products. 【Main Responsibilities】 As a Cloud Data Engineer, you'll be a Data Engineering Specialist and help us discover the information hidden in vast amounts of data. You'll be part of the team which builds a cloud data platform that runs computation jobs in the cloud for reporting & reporting and AL/ML workload. • Design, development and implement key components for highly scalable data processing pipelines to process structured & unstructured data in the cloud. • Design and develop data pipelines to extract, transform, and load (ETL) data from various sources into cloud-based data storage solutions. • Collaborate with data engineers, data scientists, data aetlnalysts and other stakeholders to understand requirements and translate them into technical specifications and solutions to support reporting and AL/ML workloads. • Work with data governance team to build the data quality check framework and ensure the data issues are monitored and tracked. • Keep abreast of emerging cloud technologies and trends in data engineering & helps the team prepare for the adoption of these technologies. • Develops a deep expertise on cloud platforms/technologies used in SHL to assist the Data & Analytics team with life cycle management or complex changes. • Helps to establish a DevOps to improve the quality, security, automation capabilities and stability of our cloud solutions.
全職
經理/總監
10/20 更新
OE - Manufacturing Project Engineer (Molding Technology) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
2年以上
【About Company】 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. This role is embedded in the Molding Technology Group within our Global Operations Engineering team in Taiwan. 【Your responsibilities】 1. Together with the rest of your team you will support the production of injection molded components for our autoinjector systems 2. Collaborate closely with shopfloor production technicians, tool makers and maintenance, quality and process development on performance/process improvements and trouble shooting 3. Lead the development of improvement plans and requirements for capacity expansion and future mold generations and production setups 4. Lead cross-functional Root Cause Analysis and Event Response Investigations 5. Lead cross-functional improvement projects and capacity deployment projects 6. Coordinate manufacturing acceptance of new molds and process in regular production 7. Coordinate Design For Manufacturing (DFM) assessments and definition of manufacturing requirements for new products
全職
中高級
英文 條件要求
10/20 更新
OE - Senior Manufacturing Engineer (Metal Forming Technology) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
5年以上
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 Compression Springs and other metal components for our autoinjector systems. • Lead the Root Cause Analysis investigations for non-conforming compression springs. • Collaborate closely with shopfloor production technicians, maintenance, quality and process development on performance/process improvements and troubleshooting. • Conduct risk assessment of the proposed process changes and suggest risk mitigation solutions. • Plan, communicate and implement Engineering Evaluation activities. • Document engineering requirements using the appropriate manufacturing document module. 【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
全職
經理/總監
英文 條件要求
10/20 更新
DET QARA - [6 month Internship] Software QA Testing 瑞健股份有限公司
待遇面議
桃園市蘆竹區
經歷不拘
In this role, We are looking for a dynamic, energetic intern who is eager to learn about what you can achieve in SHL. You will be working closely with our team to conduct software testing, attend meetings where you will be asked to participate in the design of new challenging projects and support on the efforts to keep quality to its best. To be successful as an Intern, you should be willing to help with any tasks assigned by a supervisor. You will be involved in upcoming projects as well as assisting with current tasks. You are responsible for Test firmware that employs a variety of testing methodologies such as integration, regression, performance test, etc. Prepare test plans, test cases, and execute test cases Participate peer-review test cases Create detailed bug and test reports Involve Software Development Life Cycle (SDLC) both SiMD and SaMD To succeed in this role, you should have the following skills and experience Capable of preparing test plans, test cases and execution Good knowledge of C++/C and/or Python. Experienced to operating systems such as Windows and/or MacOS, Android and/or iOS General knowledge in software security risk assessment, a plus Fluent in English or fluent Mandarin with basic English. Able to work as a team What’s on offer? An exciting opportunity in a fast-growing international medical device company A modern working environment, with multicultural and dynamic teams Learning and development. Required documents CV | Cover Letter University Transcript (all required documents in English) Engineering background preferred
兼職
初階
英文 條件要求
10/20 更新
DET QARA - (Sr.) Software QA Engineer (Automation Test) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
3年以上
*** DET(Development Emerging Technologies) QARA team is expanding in 2024! We would like to find a junior engineer and a senior engineer. *** 【About Us】 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 United States. 【In this role, you can】 Ensure full compliance, and solid product & process quality on design assurance of digital platform, software as medical device, health informatics and software component. 【Main Responsibilities】 • Design, implement, and document automatic or manual software verification plans to ensure product or in-house software quality meets the requirement specifications and medical software regulations, • Create, maintain, validate related tools used in hardware/software verification activities, • Identify software quality risks & process gaps and drive mitigation, • Provide guidance to project team members on SDLC processes & template requirements, and review software design deliverables, • Study related medical device standards/guidance and drive department improvement 【Required Skills & Qualifications】 • Bachelor's degree or higher in Computer Science or Engineering  • 2+ years in a Software/firmware Development Quality Engineering role • Fluent in python and with libraries of unittest, RestfulAPI, selenium, pyautogui • Experienced in building up automated software system, end-2-end, database testing (SQLite, MongoDB, MySQL, etc.) • Experienced in code version control tool (e.g. Git), and in project management tool (e.g. JIRA, Azure) • Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (IEC62304, ISO14971, UL2900, GAMP-5) is preferred • Result oriented, Team player, pragmatic & pro-active • English speaking/reading/writing
全職
高級
英文 條件要求
10/20 更新
RM - Risk Management Engineer 瑞健股份有限公司
待遇面議
桃園市蘆竹區
2年以上
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】 我們正在尋找撰寫風險管理檔案(RMF)的人員,你會頻繁的與客戶和內部設計及研發單位溝通合作,運用工程及法規的知識,以提供符合標準的RMF。 The role requires application of regulatory and engineering knowledge to deliver Risk Management Files (RMF) for the device designed and manufactured by SHL Medical. The candidate will work with customers and internal stakeholders such as Design and Regulatory Affairs (RA) team to outline SHL Medical’s risk management scope and deliver the RMF in compliance with but not limited to ISO 13485, ISO 14971, ISO 11608. 【Main Responsibilities】 • Participate in project intake activities to understand and assess feasibility of project proposals from risk management perspective. • Communicate and work together with customers and their representatives (clinical experts) to request and review Medical Harm List (MHL) that meets SHL requirements for intended device. • Initiate Risk Management Plan (RMP) and Hazard Identification Checklist (HIC) and align the overall risk management deliverables with internal stakeholders and customer. • Review D-FMEA and P-FMEA from design and risk assessment lead for content accuracy and the risk control measures applied for overall risk acceptance. • 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 RMF are updated periodically. Changes to RMF may be initiated by but not limited to change control, audits, design changes, regulatory requirements and customer request. • Participate in internal and external regulatory audits and inspections, including third party audits of product risk management and relevant design history files. • Ensure periodic review of post market data with supervisor and RA personnel to update device risk management file as needed. • Cascade any information from Risk Management File updates to risk assessment and project team to ensure concise communication and effective implementation of changes. • Where needed, participate and contribute on end-to-end device risk management process in SHL Risk Management improvement activities and gap remediations. • Escalate potential issues and changes that may impact device risk management files to related team members and participate in the recovery plans to ensure business risk and compliance risk are handled in timely manner. • Maintain periodic communication with customers to ensure engagement and information exchange between SHL and customer to maintain effectiveness and compliance of device RMFs. • Remain updated proactively with regulatory changes and compliance changes and escalate for discussion with Risk Manager to assess impact and changes required to risk management process and device RMFs. 【Skills and Qualification】 • Masters in Life Science Engineering discipline with 2 years of work experience (or) Degree with 5 years of work experience. Exposure to medical device, pharmaceutical or biotechnology industry is added advantage. • Trained on Quality System Regulation, Risk Management or Design Control courses. • 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.
全職
中高級
英文 條件要求
10/20 更新
QE - Senior Quality Engineer (Process - Automation&Assembly) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
5年以上
有別於常聽的到Quality Assurance(QA)和Quality Control(QC)是接近量產階段的部門,我們的Quality Engineering (QE)部門是屬於前端研發團隊中的一環。最重要的使命和任務就是,希望能大量減少產品走到量產的階段才發現問題來進行補救,而是在開發設計階段就針對品質去把關。 在醫療器材產業中,品質絕對是擺在第一位!目前部門擴大招募中,歡迎所有對於堅守產品品質有興趣的工程背景人選。 【Job Overview】 The Senior Quality Engineer of Process - Automation&Assembly is responsible for supporting new process development, automation equipment development and product transfer 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, deployment and retrofit, 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, 21 CFR Part11, ISO 13485, ISO 11608 & ISO 14971. 【Main Responsibilities】 • Represents Quality on process design, equipment development, and product transfer projects through Product Lifecycle. • Ensures that all design control and process/production control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements. • Assesses failure modes and approves the risk mitigation tool, techniques, good practices to ensure the risk management processes are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – DFMEA, PFMEA, and other risk assessment in system level. • Practices Quality Function Deployment (QFD) method to evaluate control action from Customer, Design, to Process-wise. • Promotes the use of statistics in the pre-study, engineering investigation, and in-process control based on quality aspects. • Supports Device product/process development and product transfer activities, including the following: - Consolidates or reviews lessons learned and historical data to influence product design. - Supports or reviews process/equipment specifications and requirements including system level. - Supports or reviews process/equipment verifications activity (protocols and reports) and validation/test plans. - Participates in product or process/equipment design and change activities, including qualification and reviews. - Participates in risk management activities including review failure mode effects analysis (FMEA) and/or risk or statistical analysis. - Provides technical support for product and process quality attributes/decisions. - Support selected qualification activities (e.g., advanced inspection performance check, 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.
全職
經理/總監
英文 條件要求
10/20 更新
PDPE - Project Engineer 瑞健股份有限公司
待遇面議
桃園市蘆竹區
2年以上
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 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 2 years of relevant industry experience with hands-on experience with injection molding systems and/or automation equipment. - Basic 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 - Elementary knowledge of problem-solving and Root Cause Analysis (RCA) methodologies, six sigma certification a plus. - Elementary 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. - Willing the develop technical and interpersonal skills. - 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).
全職
中高級
10/20 更新
PDMP - Senior Metrology Engineer(Application Engineer/Project Owner) 瑞健股份有限公司
待遇面議
桃園市蘆竹區
3年以上
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 a senior technical role in the Metrology Method Development group within our Global Process Development team in Taiwan. [Your responsibilities] · Develop new measurement methods for both engineering studies and mass production quality control from Design for Manufacturing (DFM) to implementation · Work cross-functionally, closely collaborate with engineers, QA/RA specialists, product management, and external contributors for project execution · Communicate detailed progress updates within cross-functional meetings · Lead investigation and improvement for the performance of existing solutions experimentally and theoretically · Structure and be responsible for corresponding work packages and, if necessary, sub-projects · Document results and present them internally as well as to customers and international development partners as needed · Laying the groundwork towards a digital twin · Other duties may be assigned · 從工程開發到量產測量方法開發 ,考量範圍包含DFM到實際執行 · 藉由跨部門合作,與工程師、品質及法規部門、產品管理單位...等密切合作,以確保專案時程順利推進 · 在跨部門溝通會議中詳細並有效地進行溝通 · 通過實驗和理論研究,領導調查和改進。 · 將專案及接續有關的子專案結構化,並記錄結果,根據需求給予內部相關單位及外部客戶。 [Your qualification] · An above-average university degree in physics, mathematics or engineering · Minimum 3 years of relevant industry experience in engineering · Experience in the development of measurement and adjustment methods highly preferred · Experience in CMM and/or CT scanning highly preferred · Experience and knowledge in Metrology (e.g. MSA) and statistic with Minitab preferred · Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus · Analytical thinking and a high level of comprehension as well as problem solving skills · Equal ability to work effectively as an individual on one’s own initiative and as part of a team in a multi-cultural and multi-disciplinarily environment. · Strong report writing and communication skills (written & verbal) in English and Mandarin · 具備物理、數學或工程學相關之學士學位(或以上) · 至少3年相關工程領域之經驗 · 有測量和調整方法開發經驗者優先考慮 · 具有CMM和/或CT掃描經驗者優先考慮 · 具有量測技術(例如MSA)和統計學知識(Minitab)優先考慮 · 具醫療、製藥相關標準知識(例如ISO13485、cGMP)者為佳 · 具有分析思維、高度理解力以及解決問題能力 · 具有跨文化和跨領域環境中獨立工作, 主動積極, 團隊合作的能力 · 具有撰寫中英文報告及良好溝通能力
全職
高級
10/20 更新