潔霺生醫科技股份有限公司 | 醫療器材製造業
新北市三重區 - 面議
- 高中
- 2年以上
職缺一:機械工程師(Mechanical Engineer – Medical Device | SolidWorks)
【工作內容】
MicroMED 是專注於醫療微機電(MEMS)與醫療藥物注射裝置的研發公司。此職位主要負責 SolidWorks 機構設計、工程圖製作、樣品試作與醫材文件,協助產品從概念走向開發與設計驗證。
主要職責:
- 使用 SolidWorks 進行零件、組立、爆炸圖與工程圖製作
- 配合設計需求進行機構細化、DFM、耐用性改善與版本管理
- 製作 BOM、圖面規格、試作紀錄,執行 ECR / ECN 設計變更
- 依 ISO 13485 醫材品質系統 撰寫與維護技術文件(DHF、SOP、WI)
- 協助樣品組裝、測試、問題分析與改善
- 與加工廠、模具廠協作,追蹤零件打樣品質
- 協助產品設計驗證(DVT)、可靠度測試、組裝治具規劃
【必要條件】
- 機械系、精密機械、工程相關科系
- 熟練使用 SolidWorks(必備)
- 具備機構設計、零件加工、材料基礎知識
- 細心、負責、邏輯性佳,能進行文件與版本管理
- 良好溝通能力,能與跨部門(R&D / 製造 / 供應商)協作
- 有與供應商合作打樣經驗
【加分條件】
- 具備 ISO 13485 或醫療器材品質系統經驗(至少 1 年)
- 具塑膠射出、模具設計、精密零件加工經驗
- 有醫療器材開發、量產、DVT 或可靠度測試經驗
- 熟悉 DFx(DFM / DFA / DFS)
- 英文讀寫佳
【薪資範圍】
具競爭力,依經驗面議
【工作地點】
新北市三重區光復路地區
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Position: Mechanical Engineer (Medical Device | SolidWorks)
[About the Role]
MicroMED is a medical device company specializing in MEMS-based microfluidics and medical drug delivery systems. This position focuses on SolidWorks mechanical design, engineering drawings, prototyping, and documentation under the medical device development process, supporting the product from concept through design validation.
Responsibilities:
- Create part, assembly, exploded views, and engineering drawings using SolidWorks
- Perform mechanical detailing, DFM, durability improvements, and version control
- Prepare and maintain BOMs, drawings, prototype records, and execute ECR/ECN design changes
- Prepare and manage technical documents required under ISO 13485 (DHF, SOP, WI)
- Support prototype builds, testing, troubleshooting, and design improvement
- Work closely with machining vendors and mold/tooling suppliers to ensure prototype quality
- Support design verification (DVT), reliability testing, and fixture/tooling planning
[Minimum Qualifications]
- Bachelor's degree in Mechanical Engineering, Precision Engineering, or related fields
- Proficiency in SolidWorks (required)
- Solid understanding of mechanical design, component manufacturing, and materials
- Strong attention to detail, responsibility, and logical problem-solving abilities
- Able to manage documentation and version control
- Strong communication skills and ability to collaborate with cross-functional teams (R&D / Manufacturing / Vendors)
- Experience working with vendors on prototyping
[Preferred Qualifications]
- Experience with ISO 13485 or medical device quality systems (1+ year)
- Background in plastic injection molding, tooling design, or precision component manufacturing
- Experience in medical device development, production, DVT, or reliability testing
- Knowledge of DFx (DFM / DFA / DFS)
- Good English reading/writing skills
[Compensation]
Competitive; commensurate with experience.
[Location]
Sanchong District, New Taipei City (Guangfu Road area)