瑞健股份有限公司

【Required Skills & Qualifications】

‧ BS degree above or equivalent technical work experience.
‧ Clear / logical thinking with strong organization and communication skills
‧ Proficient problem solving skills.
‧ Working knowledge of Microsoft Office.
‧ Experience in the medical device industry is preferred.
‧ Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
‧ CQT (certified quality technician), CQE (certified quality engineer) is a plus.
‧ Six sigma green belt or black belt is a plus.

‧ 工程學士學位以上或品質/製成相關工作經驗。
‧ 具有清晰/邏輯思維和良好的組織和溝通能力。
‧ 熟練的解決問題能力。
‧ 熟悉Microsoft Office軟體。
‧ 具有醫療器械行業經驗者優先考慮。
‧ 熟悉法規合規要求：GMP、QSR、和ISO 13485者優先考慮。
‧ 持有CQT（認證品質技術員）、CQE（認證品質工程師）證書者優先加分。
‧ 擁有六標準差綠帶或黑帶證書者優先加分。

‧ 領導/參與與專案相關的品質活動，並向團隊提供品質建議。
‧ 必須展現以客戶為導向的態度，跨部門合作技巧以及良好的品質判斷能力。
‧ 在製造過程中對觀察到的不符合項目進行評估和詳細調查。
‧ 向客戶和管理層呈現累積的品質數據。
‧ 利用統計和品質改進工具識別品質數據的趨勢，以預防品質問題再犯。
‧ 能有效地與外國客戶、團隊成員和各種技術專業互動和溝通。
‧ 支援外部品質檢查並執行內部和供應商審核。
‧ 能在時間內主動積極的完成被分配的任務

• Bachelor degree, ideally in Computer Science or Information Systems
• 1+ Years of IT related experience in the following technologies:
○ Microsoft Active Directory with Microsoft Azure Active Directory hybrid-join environment
○ Microsoft Windows clients (7, 10, 11)
○ Microsoft Windows Printer Server and any third party certral printer management solutions such as PaperCut
○ Muti-functional printers, office printers and label printers
○ Meeting room technologies (projector, TV, wireless presentation, AV, VC, room reservation terminal and etc)
• Willing to participate in rotation shifts (08:00 – 20:00 or 20:00 – 08:00)

(詳細資訊請參考以下104連結)

• Act as the first point of contact for users seeking technical assistance over the ITSM ticketing system, phone or email
• Assist users on identifying issues and requests and maintaining the tickets in IT Service Management system within SLAs
• Lead troubleshooting and root cause analysis to effectively resolve issues and deliver sustainable solutions in collaboration with technical peers
• Monitor client infrastructure health and keep track of their availability, performance, and responsiveness
• Support in evaluation and purchasing of IT hardware/software solutions
• Perform IT asset management

(詳細資訊請參考以下104連結)

【Required Skills & Qualifications】
• Bachelor's degree or higher in Computer Science or Engineering
• 2+ years in a Software/firmware Development Quality Assurance role
• Fluent in C/C++, or C#, python programming language
• Experienced in building up software system/functional/integration test cases and analyzing architecture/module interaction between software components
• Experienced in development Quality/testing role in medical device industry is a plus
• Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (EU:MDR, IEC62304, ISO13485, ISO14971, UL2900) is preferred
• Result oriented, Team player, pragmatic & pro-active
• Good at English listening/speaking/reading/writing

【Main Responsibilities】
• Establish software testing plans to deliver quality for medical software intended uses, safety, and security
• Responsible for developing and maintaining software testing pipelines for automatic or manual testing to improve software quality
• Responsible to review software tool validation to ensure the tools used in product development, test and operation processes are fully validated to fulfill intended uses
• Align with customer quality governance model for design & development projects
• Provide guidance to project team members on processes & template requirements, and reviewing software design deliverables

【Required Skills & Qualifications】
• Bachelor’s degree in engineering or science
• Hands-on experience in designing and carrying out tests of mechanical products
• Expertise in fixture design and modal analysis of mechanical test fixtures
• Profound knowledge of mechanical validation testing and data acquisition
• Ability to automate mechanical tests
• Knowledge in metallurgy and data acquisition analysis
• Skilled to perform statistical analysis
• Knowledge of industrial manufacturing procedures
• Proficiency English skill with written and verbal communication is required in an international team and with SHL’s sites overseas. (TOEIC 800 or above)
• Knowledge of Good Laboratory Practice (GLP) and Good Documentation Practices (GDP) is required.

• Develop engineering test plan in the early phase of product development to provide direction to adjusting the design
• Support realizing design prototype
• Reviewing the product designs and noting likely points of failure.
• Reviewing existing engineering criteria for similar products.
• Meeting with product designers and apply regulatory standards to determine functionality test method
• Develop design verification methodology based on product designs and failure points.
• Conduct the Test Method development and validation activity include fixture development, method validation protocol/report.
• Writing up final test procedures and training QC staff.
• Execute regular equipment maintenance, calibration and status check.
• Assign above job tasks by staffing qualification / personal ability / organization needs.
• Carry out other duties as assigned.

【Required Skills & Qualifications】
• Bachelor’s degree in Mechanical Engineering or similar, ideally combined with 1-3 years of work experiences
• In-depth knowledge of mechanical design and passion for testing technology
• Skilled in structured problem solving, analytical and logical thinking
• Strong organizational and project management skills
• High level of independence, positive and curious attitude
• Familiar with 3D design software (SolidWorks or other CAD) and technical drawings
• Proficient in English (TOEIC 700 or above)
• Project management skills to lead projects according to timelines

【Main Responsibilities】
• Establish end-to-end test solutions, from identification of requirements to implementation of test equipment’s
• Drive cross-department projects for new test solutions or continuous improvement of existing test solutions
• Communicate and collaborate with global team members, test equipment vendors and customers
• Conduct technical activities including design review, engineering studies, test method development and validation
• Perform problem solving and root-cause-investigation, including collaboration with designers, simulation, and statisticians
• Build up the center of competencies from testing technologies, and create guidance for knowledge sharing
• Actively participate in standardization and process improvement activities
• Opportunity to work globally at the oversea sites of SHL Medical, including the US, Switzerland and Sweden office

● Degree in Engineering, Polymer Science or similar education/experience

● Several years of relevant experience in manufacturing of packaging components and/or printing technologies
● Expertise in one or more of the following: Vacuum / Thermo Forming (trays, blisters), Automated Printing Processes (e.g. laser/UV/Pad/Screen), Polymer Coating Processes, Packaging design and development
● Statistical analysis knowledge, including an understanding of how to execute Design of Experiments (DOE). Six Sigma certification is a plus.
● Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies
● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done
(詳細要求條件請看以下104連結)

【Your responsibilities】

● Together with the rest of your team you will support the production of packaging material and component printing processes for our autoinjector systems
● Lead engineering responsibility for packaging production lines and printing processes within our production system
● Collaborate closely with shopfloor production technicians, maintenance, quality and process development on performance/process improvements and trouble shooting
● Lead the development of improvement plans and requirements for capacity expansion and future packaging and printing concepts
● Lead improvement initiatives and capacity deployment in packaging and printing
● Responsible for manufacturing acceptance of new packaging and printing processes in regular production
● Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products

Your qualification
- Degree in Engineering, Material Science or similar education/experience
- Relevant industry experience in manufacturing / metal forming / equipment or component design / automation / product industrialization (For the right candidate who is keen to learn, this could also be your first job after graduation)
- Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done
- Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost
- Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies (6 sigma / DMAIC, 8D, A3) is a plus

Your responsibilities
- Together with the rest of the team you will support the production of metal components (e.g. coil springs, guide rods, brackets) for our autoinjector systems
-Own engineering responsibility for specific production/product lines and corresponding processes within our production system
- Collaborate closely with shop floor production technicians, maintenance, quality and process development on performance/process improvements and trouble shooting
- Support the development of improvement plans and requirements for capacity expansion and future metal component production
- Support the execution of improvement initiatives in metal component production

Your qualification
- Degree in Mechanical Engineering, Polymer Science or similar education/experience
- Relevant industry experience in manufacturing / injection molding / mold making / product industrialization (For the right candidate who is keen to learn, this could also be your first job after graduation)
- Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done
- Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost
- Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies (6 sigma / DMAIC, 8D, A3) is a plus
- Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written)

Your responsibilities
- Together with the rest of the team you will support the production of injection molded components for our autoinjector systems
- Own engineering responsibility for specific molds/components and corresponding processes within our production system
- Collaborate closely with shop floor production technicians, tool makers and maintenance, quality and process development on performance/process improvements and trouble shooting
- Support the development of improvement plans and requirements for capacity expansion and future mold generations
- Support the execution of improvement initiatives in injection molding

● Degree in Engineering or equivalent education/experience in a relevant field
● Several years of relevant hands-on manufacturing experience with highly automated high-volume production systems
● Hands-on experience with designing, developing and maintaining complex automated equipment is highly desirable
● Familiar with Siemens PLC based systems, sensor, actuator and vision technologies, SCADA
● Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams
● Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies; Six Sigma certification is a plus.
● Passionate & committed self-starter with “can do” attitude, team player and taking responsibility to get the job done
(詳細內容請看以下104連結)

● Improve system & equipment reliability for the core processes to meet all customer, business & regulatory requirements

● Together with the rest of your team you will support the production for automated assembly of our autoinjector systems
● Lead engineering responsibility for production/product lines and corresponding assembly processes within our production system
● Collaborate closely with shopfloor production technicians, equipment builders and maintenance, quality and process development on performance/process improvements and trouble shooting
(詳細內容請看以下104連結)

You are
· Student in Engineering, Applied Sciences or other equivalent education
· Independent thinker who is willing to discover new solutions off the beaten tracks
· Interest in advanced high-volume production technologies, process improvement and medical manufacturing
· Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Packaging or Polymer Technology, Industrial printing processes (Pad, Screen, Laser), Packaging design
· Strong intercultural and interdisciplinary communication skills in English (spoken/written)
· Diligent, reliable and target oriented team player

包裝、貼標等製程改善及優化相關專案

You are

· Student in Engineering, Applied Sciences or other equivalent education
· Independent thinker who is willing to discover new solutions off the beaten tracks
· Interest in advanced high-volume production technologies, process improvement and medical manufacturing
· Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Engineering components (springs, screws, etc.), Metal cold forming processes, Chemical cleaning processes
· Strong intercultural and interdisciplinary communication skills in English (spoken/written)
· Diligent, reliable and target oriented team player

金屬成形製程改善及優化相關專案

You are
· Student in Engineering, Applied Sciences or other equivalent education
· Independent thinker who is willing to discover new solutions off the beaten tracks
· Interest in advanced high-volume production technologies, process improvement and medical manufacturing
· Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Polymer Science, Plastics Engineering, Injection Molding / Tooling Technology, Product Development, Process Development
· Strong intercultural and interdisciplinary communication skills in English (spoken/written)
· Diligent, reliable and target oriented team player

塑膠射出成形製程改善及優化相關專案

You are
· Student in Engineering, Applied Sciences or other equivalent education
· Independent thinker who is willing to discover new solutions off the beaten tracks
· Interest in advanced high-volume production technologies, process automation / robotics, control engineering, equipment design and medical manufacturing
· Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Process Automation, Digital Manufacturing/I4.0, Control Engineering, Equipment design, Robotics
· Strong intercultural and interdisciplinary communication skills in English (spoken/written)
· Diligent, reliable and target oriented team player

自動化組裝製程改善及優化相關專案

You are
· Student in Engineering, Applied Sciences, Business Administration or Management
· Independent thinker who is willing to discover new solutions off the beaten tracks
· Previous experience / training in Project and/or Operations Management
· Knowledge of common collaboration and productivity tools in MS O365
· Interest in Project Analytics, Continuous Improvement, Operations Management
· Strong intercultural and interdisciplinary communication skills in English (spoken/written)
· Diligent, reliable and target oriented team player
· Knowledge of JavaScript, Python or VBA is a plus

量產製程優化及資料分析相關專案

You are
· Student in Engineering, Applied Sciences or other equivalent education
· Independent thinker who is willing to discover new solutions off the beaten tracks
· Interest in advanced high-volume production technologies, process automation / robotics, control engineering, equipment design and medical manufacturing
· Knowledge and/or previous experience in one or more of the following fields: Lean Manufacturing and Six Sigma methodologies, Process Automation, Digital Manufacturing/I4.0, Factory planning, Logistics, Plant simulation
· Strong intercultural and interdisciplinary communication skills in English (spoken/written)
· Diligent, reliable and target oriented team player
· Knowledge of JavaScript, Python or VBA is a plus

量產製程技術移轉相關專案

1.Good command of English communication ability.
2.Good communication and coordination abilities.
3.Good presentation skills.
4.Customer service-oriented.
5.Contribute to the whole.
6.Above 2 years of experience in project management will be a plus.
7.Engineering major is a plus.

Responsibilities :

1.Allocate resources required to execute a project.
2.Create the official project schedule. Review schedule with customer and project team.
3.Organize all the project activities and follow-up.
4.Organize project kick-off, design review, and project status update meetings.
5.Follow up on action items of kick-off, design, and project status update review meeting.
6.Provide project status reports to management weekly or under request.
7.Monitor and ensure engineering design and documentation are on time and complete.
8.Root cause analyzing and problem-solving for project issue
9.Support FAT with the customer.
10.Support actions to customer service requests and complaints.
11.Execute approved customer changes, update the official schedule as needed.
12.Proactively identify and manage the risks of the project.

/Skills & Qualification/

• Degree in Molding / Tooling / Mechanical Engineering.
• Ability to learn PM methodologies and tools for scheduling and time management.
• Experience with plastic injection molding or tooling machining process is preferred.
• Strong intercultural and interdisciplinary communication skills; excellent written and verbal English ability.
• Experience in international collaboration programs and good at building professional networks.
• Able to work under pressure to achieve short-term targets without compromising long-term objectives.
• Capable of handling communication and cooperation with stakeholders over distance.
• High capacity of critical thinking and problem solving.
• Capable of prioritizing tasks and working efficient to meet project deadlines.
• Effective communication and negotiation skills.

/Job responsibilities/

• Assist to plan and manage all aspects of the project lifecycle (design, engineering, tech transfer, validation, launch, scale-up, etc.).
• Assist to coordinate with various teams to have mitigation plans when major project issues and potential risks are identified.
• Establish and maintain appropriate structures to ensure communication, flow of information and documentation within the project.
• Responsible for project deliverables, schedule, cost and quality as well as reporting to team leader.
• Cross-functional role with strong interaction with various departments, internal stakeholders, suppliers, and customers.