智慧型裝置事業群-產品專案經理(內湖) - TWSA14271

1. 醫療器材品質管理系統活動之推行 (ISO13485/QMS)：主導內部稽核、管理審查安排與執行，維護公司品質系統相關業務，例如品質目標、品質系統文件 

2. 因應公司醫材販售各國/區域醫療器材品質管理系統要求導入 (FDA QSR, TFDA QMS, 日本、澳洲… 

3. 3rd party、主管機關之溝通

1. 成本建模與分析工具管理  

●建立、維護並優化成本分析模型（Should-cost、BOM cost、Cost Structure）  

●進行結構化成本拆解，提供可支援採購決策的分析結論  

●持續優化分析流程與工具，提升成本分析品質與效率  

●Develop, maintain, and optimize cost analysis models (Should-cost, BOM cost, cost structure)  

●Perform structured cost breakdown analysis to support procurement decision-making  

●Continuously improve cost analysis processes and tools to enhance quality and efficiency  

2. 成本趨勢辨識與溝通  

●透過成本分析與專案資料，辨識原物料與零組件之成本上升趨勢,與相關單位提示已上漲或具上行風險之材料項目及其影響  

●Identify cost uptrend signals in raw materials and components through cost analysis and project data  

●Proactively notify relevant stakeholders of materials with confirmed or potential cost increases and impacts  

3. 成本優化與 Cost-down 專案管理  

●規劃、推動並追蹤 Cost-down / 成本優化專案  

●管控專案進度與成果，量化實際成本節省效益  

●跨部門單位協作，確保專案執行成效  

●Plan, drive, and track cost-down, and cost optimization initiatives  

●Manage project progress and quantify realized cost savings  

●Collaborate with teams to ensure execution effectiveness  

4. 專案監控與決策支援  

●定期產出成本與專案分析報告  

●識別成本偏差與潛在風險，支援管理層進行成本評估與專案決策  

●Prepare regular cost and project analysis reports  

●Identify cost deviations and support management reviews and decision-making processes  

※依學經歷、工作年資敘薪

1. 審查與協助建立公司醫療產品技術文件。 

2. 協助醫療器材安規測試送測與認證取得。 

3. 管理追蹤各國醫療法規與公司產品適用法規確認並對公司內部同仁教育訓練 

4. 國內外醫療器材產品認證註冊申請作業(FDA/TFDA/CFDA/CE)

1. 帶領專案團隊人員共同達成專案目標 

2. 新產品開發專案規劃，時程管理，並統籌各研發部門工作、跨部門溝通協調 

3. 產品量產導入：含生產計畫、物料準確性到試產、生產期程等 

4. 產品開發驗証作業評估及執行與技術文件之撰寫

1.BOM/CTO/BTO流程之管理  

2.試產材料之準備  

3.研發專案之追蹤與控管  

4.與PM合作進行專案管理 

※依學經歷、工作年資敘薪

1. Lead RFQ Process: Manage request-for-quotation activities, including proposal review and calculation of NRE and unit costs. 

2. Oversee NPI Performance: Drive overall New Product Introduction (NPI) production performance and troubleshooting to ensure a successful transition to mass production. 

3. Manage NPI Projects: Ensure projects meet the required schedule, cost targets, and performance objectives. 

4. Project Planning & Execution: Responsible for comprehensive project management, including planning, risk control, and facilitating the introduction of new products into mass production. This involves scheduling, engineering quality assurance, process control, coordination, and follow-up to meet client requirements. 

5 .Develop SOPs and Guidelines: Establish and align standard operating procedures and process guidelines with clients for existing workflows. 

6. Additional Duties: Perform other related responsibilities as assigned. 

***依學、經歷敘薪 ***

負責協作機器人專案之規劃、執行與跨部門協調，作為業務端與客戶之間的主要窗口，定義產品規格、任務流程與導入範圍，並統籌研發資源、控管專案進度、風險與里程碑，確保專案如期、如質完成。需具備技術理解力、跨部門溝通能力，以及帶領團隊執行專案的經驗。 

主要職責（Key Responsibilities） 

1. 需求與規格定義（Requirement Definition） 

- 與業務、客戶端窗口共同盤點需求 

- 進行場域訪查，理解客戶需求 

- 產出：SOW、需求文件（PRD / MRD）、流程圖、技術規格書 

- 明確定義專案範圍與不可變動項目（Scope Control） 

2. 跨部門協作與專案執行（Project Execution） 

- 協調研發（RD）、軟體、硬體、測試、工程等內部資源 

- 制定專案時程（Timeline）、里程碑（Milestones）、交付物（Deliverables） 

- 追蹤日/週進度，確保專案準時完成 

- 管理文件，包括 SOP、架構圖、測試計畫、驗收規範 

3. 風險控管（Risk Management） 

- 建立專案風險清單（Risk Register） 

- 預測潛在阻礙、風險、資源瓶頸，提出應對方案 

- 協助團隊做優先級排序（Prioritization） 

4. 醫院端溝通與驗收（Client Communication） 

- 向內外部客戶解釋系統功能、限制與導入計畫 

- 協助定義工作流程（Workflow）與任務派送規則 

- 安排 PoC、trial run、驗收 

- 收集現場回饋，回饋研發優化產品 

5. 團隊領導與管理（Team Leadership） 

- 帶領跨功能專案團隊（Software / Firmware / Hardware / Field） 

- 促進共識、排除障礙、協助決策 

- 指導初階 PM 或實施人員（Implementation）

1. 試產備料管理、配合試產任務安排出差。 

2. Sample出貨及Logistic安排。 

3. 研發、生產的相關任務執行及即時管理。 

4. 初階專案管理及團隊分工協調。

1.無線認證流程規劃及時程控管。 

2.無線認證申請。 

3.無線認證成本控管。 

4.各國無線認證法規研究。 

※依學經歷、工作年資敘薪

1. RFQ/NPI/Post RTS activities coordination , prepare RFQ proposal , issues driving.  

2. NPI phase travel budget/proto budget control and build activities coordinate among customer , internal teams.  

3. Cross function co-ordination among RD/suppliers/RD/Validation team..and Customers.  

4. Overall schedule control to meet major milestone.ol to meet major milestone.

1. 針對Functional Safety & Cyber Security與客戶端窗口溝通彼此的R&R  

2. 工程要求的開展及進度追踪  

3. Work products的產出/整理/提交  

※依學經歷、工作年資敘薪

1. Lead RFQ Process: Manage request-for-quotation activities, including proposal review and calculation of NRE and unit costs. 

2. Oversee NPI Performance: Drive overall New Product Introduction (NPI) production performance and troubleshooting to ensure a successful transition to mass production. 

3. Manage NPI Projects: Ensure projects meet the required schedule, cost targets, and performance objectives. 

4. Project Planning & Execution: Responsible for comprehensive project management, including planning, risk control, and facilitating the introduction of new products into mass production. This involves scheduling, engineering quality assurance, process control, coordination, and follow-up to meet client requirements. 

5 .Develop SOPs and Guidelines: Establish and align standard operating procedures and process guidelines with clients for existing workflows. 

6. Additional Duties: Perform other related responsibilities as assigned.

1. 新舊客戶開發及管理 

2. 業績目標達成 

3. 工廠端下單、出貨及相關問題處理 

4. 業務助理管理 

5. 需定期出差

協調資源確保專案運作符合計畫 

協助衍生客制化產品 

協助工程師彙整文件並管理相關文件與檔案 

協助產品認證相關文書作業 

製作產品規格及說明書