瑞健股份有限公司

Company Introduction

5000 Employees
桃園市蘆竹區六福路36號
Contact Person
人力資源部
Phone
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.

Industry Sector
醫療器材製造業

Main Products

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

Benefits

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

Jobs

Testing - Design Verification Engineer 設計驗證工程師 瑞健股份有限公司
Salary negotiable
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. ***
Full-time
Entry-level
English Required
10/01 Updated
QE - Quality Engineer (Process - Molding&Tooling) 瑞健股份有限公司
Salary negotiable
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
Full-time
Mid to Senior Level
English Required
10/01 Updated
QE - Quality Engineer (Process - Automation&Assembly) 瑞健股份有限公司
Salary negotiable
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.
Full-time
Mid to Senior Level
English Required
10/01 Updated
RM - Risk Management Engineer 瑞健股份有限公司
Salary negotiable
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.
Full-time
Mid to Senior Level
English Required
10/01 Updated
QE - Senior Quality Engineer (Process - Automation&Assembly) 瑞健股份有限公司
Salary negotiable
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.
Full-time
Manager/Director
English Required
10/01 Updated
Testing -【6-month Internship】Design Verification Intern 瑞健股份有限公司
部分工時(月薪) NT$ 21,500~43,000
桃園市蘆竹區
經歷不拘
【About the 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. 【Job Overview】 We are seeking intern who is aspiring, energetic, responsible to join growing organization. The candidate can ideally be a current student in part time or recent graduate in full time of engineering program. In this role, you will experience how Medical Device design verification and test method development is completed in a world-leading solution provider advanced drug delivery systems. Participation in this program requires that you are located in the Taiwan for the duration of the engagement. This is a 6-month internship program. The intern needs to come to office at least 3 days a week. 【Main Responsibilities】 Participate in research and product development projects to address real-world problems in medical device industry. 【Preferred qualifications】 · Ability to speak and write in English fluently. · Relevant experience in student projects or competitions. · Experience contributing research communities or efforts, including publishing papers in conferences or journals. · Exhibit the capability to think analytically, target-oriented and structured. 【Required documents】 CV|Cover Letter University Transcript (all required documents in English) *Engineering background preferred*
Full-time
Entry-level
English Required
10/01 Updated
OE - Principal / Senior Manufacturing Engineer (Spring Technology) 瑞健股份有限公司
Salary negotiable
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
Full-time
Manager/Director
English Required
9/30 Updated
OE - Plant Simulation Engineer (Factory Planning) 瑞健股份有限公司
Salary negotiable
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
Full-time
Senior Level
English Required
9/30 Updated
OE - Project Engineer (Factory Automation & Equipment) 瑞健股份有限公司
Salary negotiable
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
Full-time
Senior Level
English Required
9/30 Updated
OE - Manufacturing Project Engineer (Molding Technology) 瑞健股份有限公司
Salary negotiable
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
Full-time
Mid to Senior Level
English Required
9/30 Updated
OE - Senior Manufacturing Engineer (Metal Forming Technology) 瑞健股份有限公司
Salary negotiable
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
Full-time
Manager/Director
English Required
9/30 Updated
PDMP - Senior Metrology Engineer(Application Engineer/Project Owner) 瑞健股份有限公司
Salary negotiable
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
Full-time
Senior Level
9/30 Updated
Project Management - Project Manager 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
5年以上
SHL's PM team is expanding in 2024! We are lookng for experienced talents to work with us! 【Job Overview】 A dedicated and experienced Project Manager with strong technical background, attention to detail and a background in product development and industrialization in the medical device or pharma industry. 【Main Responsibilities】 。Lead new product introduction projects with a multi-disciplinary team of highly skilled experts. 。Plan and manage all aspects of the project life cycle (design, engineering, tech transfer, validation, launch, scale-up). 。Establish and maintain appropriate structures to ensure communication, flow of information and documentation within the project. 。Responsible for project deliverable, schedule, cost and quality as well as reporting directly to relevant stakeholders within the organization. 。Cross-functional role with strong interaction with various departments, internal stakeholders, suppliers and customers. 。Ensuring effective implementation of requirements enabling fast ramp up of production and benefit realization. 【We offer】 。Modern & variety of culture 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 organisation. 。Flexible working hours and WFM policy.
Full-time
Manager/Director
English Required
Partially Remote
9/30 Updated
PDCP - Manufacturing Technology Development Engineer 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
2年以上
【Job Overview】 As a Manufacturing Technology Development Engineer in our Component Process Development department (PDCP), you are responsible for the evaluation, development, implementation, and qualification of advanced manufacturing processes for our diverse component portfolio. The primary focus lies on manufacturing processes for metal components, such as spring forming, metal stamping, cold forming, heat treatment, as well as chemical cleaning and automated inspection. 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 manufacturing equipment for components of medical devices • Innovate, co-develop, and optimize advanced mass production processes for metal components • Drive cross-departmental project activities together with our Process Development, Project Management, 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), factory and site acceptance (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 IQ, OQ, PQ runs • Act as the main 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
Full-time
Mid to Senior Level
9/30 Updated
OE - Senior Project Engineer / Technical PM (Molding Technology) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
5年以上
【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. • 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 cross-functional Root Cause Analysis and Event Response Investigations. • Lead cross-functional improvement projects and capacity deployment projects. • Coordinate manufacturing acceptance of new molds and process in regular production. • Coordinate Design for Manufacturing (DFM) assessments 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 the global organization
Full-time
Manager/Director
English Required
9/30 Updated
OE - Senior Manufacturing Engineer (Thermoforming Technology) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
5年以上
【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 thermoforming (e.g. tool development, pressure and vacuum forming) for our auto-assembly systems ● Lead engineering responsibility for tray manufacturing and corresponding 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 tray tool development and regular turnover tray production ● Lead improvement initiatives and capacity deployment tray production ● Responsible for manufacturing acceptance of new tray forming equipment / 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
Full-time
Manager/Director
English Required
9/30 Updated
OE - Principal Manufacturing Engineer (Assembly Process & Equipment) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
10年以上
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 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 • Lead critical event response and cross-functional root cause investigation teams • 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 commissioning and acceptance testing of new production equipment. • Manage technology transfer (receiver function) of new equipment into mass production. • Lead validation activities for new equipment and processes as necessary 【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
Full-time
Executive Level
English Required
9/30 Updated
OE - Principal Engineer (Molding Technology) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
10年以上
【Job Overview】 This role is embedded 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. 【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 the global organization
Full-time
Executive Level
English Required
9/30 Updated
OE - Senior Project Engineer (Factory Planning) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
5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】 • 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.) 【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
Full-time
Manager/Director
English Required
9/30 Updated
OE - Senior Project Manager (Operations) 瑞健股份有限公司
Salary negotiable
桃園市蘆竹區
6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. 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
Full-time
Manager/Director
English Required
9/30 Updated