TS Security Engineer(資安合規顧問/工程師）
UL Solutions · Taipei, Taiwan
Professional Services · 10,001+ employees
About the role
The Security Engineer will evaluate the security and development processes of connected medical devices to ensure compliance with international standards like the EU CRA and FDA guidelines. They will also provide technical consulting, conduct risk assessments, and support engineering teams in implementing secure design practices.
What they look for
Requirements
Candidates should hold a bachelor's degree or higher in Computer Science, Cybersecurity, Software Engineering, or Biomedical Engineering. Proficiency in Secure SDLC, threat modeling, and experience with medical device or IoT security regulations is highly preferred.
Benefits
Full description
身為安全科學領域的全球專家，(美商) UL Solutions (NYSE: ULS) 將全球超過 100 個國家客戶的產品安全、資訊安全和永續性挑戰轉變成機會。UL Solutions 提供測試、檢驗與認證服務，連同所需的軟體產品和諮詢服務，以支援客戶的產品創新與業務成長。台灣辦公室位於台北、林口、蘆竹、新竹。
負責評估連網醫療設備（Connected Medical Devices）、數位健康產品與軟體系統之資安與安全開發流程（Secure Development Lifecycle, SDL），確保其符合歐盟《Cyber Resilience Act (CRA)》、FDA醫療資安指引及 IEC 81001-5-1 等國際標準。 職責涵蓋產品設計開發階段至上市後監控（Post-market Surveillance），對產品進行風險分析、漏洞管理、文件審查與測試驗證，並支援工程團隊導入安全設計（Secure by Design）與安全開發實務。 服務領域包括數位醫療（Digital Health）、智慧醫療設備、IoMT（Internet of Medical Things）、遠距醫療與醫療軟體（SaMD/SiMD）等多元醫療生態系。 提供客製化專業服務，包含專案規劃、安全開發流程導入、合規評估、技術培訓、文件建立與審查。並依據客戶與主管機關（EU/FDA）要求撰寫正式評估與技術報告。
職務說明
- 支援產品符合以下法規與標準之資安與安全開發要求與導入：
o EU Cyber Resilience Act (CRA) o FDA Cybersecurity for Medical Devices (Premarket & Postmarket) o IEC 81001-5-1（醫療軟體安全開發） （延伸：ISO 13485、ISO 14971、IEC 62304）
- 評估醫療產品與軟體之：
o Secure Development Lifecycle（SDL）導入情況 o 威脅建模（Threat Modeling）與風險管理 o 漏洞管理（Vulnerability Management）與SBOM o 身分與存取控制、資料保護與加密機制等安全控制
- 審查技術文件與法規文件，包括：
o Cybersecurity Risk Management File o FDA Premarket Submission 資安文件 o CRA 技術文件與符合性聲明
- 支援專案管理團隊：
o 定義評估範圍與資源規劃 o 與Notified Body / FDA / 客戶對齊要求 o 確保專案時程與交付品質
- 與客戶團隊合 作：
o 建立並優化安全開發流程（Secure SDLC） o 導入DevSecOps、安全測試與漏洞管理流程
- 追蹤醫療資安與法規趨勢（EU、FDA）：
o 參與研討會、撰寫技術文章與白皮書 o 建立並分享內部專業知識
- 支援內部與客戶：
o 提供高階技術諮詢（安全設計、合規策略） o 教育訓練（安全開發、醫療資安法規、各國資安法規） o 文件與流程建置
- 支援業務團隊：
o 提供技術提案與解決方案 o 推動高階醫療資安與合規專案
- 其他主管交辦事項
■ What you’ll experience working at UL:
- Mission: For UL Solutions, corporate and social responsibility isn’t new. Making the world a safer, more secure and sustainable place has been our business model for over 125 years and is deeply engrained in everything we do.
- People: Ask any UL Solutions employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is possible is the standard at UL Solutions. We’re able to deliver the best because we employ the best.
- Interesting work: Every day is different for us here as we eagerly anticipate the next innovation that our customers create. We’re inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
- Grow & achieve: We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
- Total Rewards:
o Competitive remuneration package
o Friendly environment and collaborative colleagues
【福利制度】
- 保障年薪 14個月 + 績效獎金
- 休假制度: 優於勞基法的休假制度 (第一年有15天的特別休假)
- 保險類: 1.勞保 2.健保 3.員工團保 4.眷屬團保
- 福委會: 團體旅遊、社團活動、生日禮券、節慶禮品/禮券
- 年終尾牙聚餐、部門聚餐、Team Building
- 週休二日; 每週工作時數 38.75 小時
- UL Solutions 重視員工的保障、激勵及愉快的工作環境、並提供相關訓練
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers’ product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers’ products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.
Imagine getting your hands on new technology before it hits the shelves. To dig deep and figure out exactly how it works. That’s what we do. We lift the lid and test the boundaries on a huge range of products, from health-monitoring smart watches monitoring to electric vehicles loaded with the latest software. We’re always looking for people who are passionate about innovation, embrace change and love new and exciting challenges. Join our team, influence emerging technology and forge a successful career at the center of safety science.
