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.

【Main Responsibilities】
‧ Develop and deliver training programs on RCA methodologies, tools, and best practices.
‧ Conduct workshops, seminars, and hands-on training sessions to enhance the RCA skills of investigation Plan owners.
‧ Provide coaching and mentorship to individuals or teams to improve their RCA capabilities.
‧ Monitor the performance of RCA investigations across various projects or departments.
‧ Analyze investigation outcomes and identify areas for improvement.
‧ Implement KPIs to measure the effectiveness and efficiency of RCA processes.
‧ Continuously evaluate and refine RCA processes and methodologies to ensure effectiveness and efficiency.
 

For more information, please check SHL Career website

【Required Skills & Qualifications】
• 具有機械工程學位或類似專業的大學學位以上；如有1-3年的工作經驗為佳
• 具一定深度機械設計之知識，並對製造技術充滿熱情
• 如具有彈簧製造、冷成型技術、沖壓技術或類似領域的經驗為佳
• 擅長結構化解決問題和邏輯思維
• 出色的組織和專案管理能力
• 獨立自主、樂觀好奇的態度
• 強烈的追求卓越的動力
• 有效的溝通和簡報技巧，能夠將複雜訊息傳達給不同領域的相關者
• 熟悉閱讀技術圖面；具3D設計軟體（Solidworks或其他CAD）技能為佳
• 具有量測方法開發、製程失效模式分析、可製造性設計評估流程、製程管制、統計分析及品質保證與管制概念或類似經驗為佳

• 熟練的英語能力（TOEIC 600或以上）

• 熟練的中文能力（CEFR B2或以上）

1. 開發先進和優化金屬零件的大批量生產製程，包括試生產協調和執行（基準測試、優化、驗證和確認測試）
2. 推動與專案相關的製程工程、專案管理、供應鏈、製造和品質團隊之間的開發任務及跨部門協調
3. 發起相關研究任務和實驗（如實驗室分析或與大學合作），進行根本原因分析，證明新技術、材料、工藝和設備的適用性
4. 管理所有專案技術方面問題，包括系統性地進行解決問題活動、測試和評估任務
5. 領導供應商的技術發展並協調外包金屬零件的資格驗證活動
6. 推薦新的或替代的技術、製程和設備，為內部創新和工藝發展計畫做出貢獻
7. 確保所有相關規格並遵守法規要求

【Qualification】

1. Bachelor’s or Master's degree in engineering or a related science field.
2. Hands-on experience in designing and testing mechanical products.
3. Experience in designing fixtures and analyzing mechanical test setups.
4. Strong problem-solving and analytical skills.
5. Strong knowledge of mechanical validation testing and data collection.
6. Understanding of material failure analysis or data analysis.
7. Skills in statistical analysis.
8. Ability to automate mechanical tests.
9. Familiarity with industrial manufacturing processes.
10. Knowledge of Good Laboratory Practice (GLP) and Good Documentation Practices (GDP).
11. Excellent written and verbal communication in English.
12. Good interpersonal skills and a team-oriented mindset.

【Responsibilities】

1. Verify the design, materials, and components of medical devices for various product generations at both component and system levels.
2. Develop and integrate test plans and methods across different verification environments.
3. Create and verify test methods, including developing fixtures and writing verification reports.
4. Conduct studies on drug delivery systems to support worst-case test scenarios.
5. Help develop and test design prototypes.

【需求條件】
1. 具備英文溝通能力 (多益 700 以上者佳)
2. 文書處理、OFFICE
3. 具設備、模具開發經驗者佳
4. 具備SolidWorks或AutoCAD繪圖能力者佳
5. 具備以 Python, VB, C#, SQL 撰寫程式進行資料處理/應用經驗者佳
6. 其他: 具團隊合作、學習意願高、善於溝通

【工作職掌】
● 自動化生產設備學習
● 生產異常缺陷分析及根因調查
● 新技術評估、設備開發、導入
● 針對效率、良率、成本對現有製程進行改善
● 改善專案提案與進度管控
● 主導部門間專案合作
● 協助公司新建廠區規劃
● 基礎Office使用 (報告處理、資料統計分析、文件編寫)