• Provide on-site leadership for project team by building and motivating multidisciplinary team members to meet project goals, adhering to their responsibilities and project milestones.
• Clarify the requirements from the customers and medical device regulations, and propose software requirement document.
• Manage the SaMD (Software as a Medical Device) development project and optimize among specification, resource and timeline.
• Coordinate internal resources and third parties/vendors for the flawless execution of projects.
• Create and maintain comprehensive DHF (Design History File) for each SaMD in accordance with QMS and medical device regulations.
• Ensure all development processes and deliveries complying with regulations for medical devices, information security and privacy.
•Bachelor's degree in related medicine discipline, medical engineering discipline or information systems required. Master’s degree in related field strongly preferred.
•2+ years in software management with successful cases on communicating with customers and development teams.
•Excellent English written/oral communication skills required.
•Familiar with Taiwan Pharmaceutical Affairs Act and ISO13485 required.
•Familiar with ISO 27001, GDPR, and HIPAA is a plus.
•Familiar with DICOM, HL7 or other health care interoperability standards is a plus.
•Experience with SaMD, PACS or RIS development is a plus.
•Experience with medical device development management is a plus.
•Experience with software development with AI technologies is a plus.
新北市新店區中興路三段 88 號
HTC 致力於將智慧融入生活之中，為全球智慧行動裝置與科技的創新先驅。我們創造的 VIVE Reality，結合 VR、AR、AI、5G、Blockchain 尖端科技，除了持續打造再進化的硬體及軟體，創造出具有絕佳體驗與革命性效能的產品外，也推出對企業、文化、藝術、教育、醫療及娛樂具有深刻意義的內容，呈現令世界耳目一新的成果。 2022 年我們向世界揭示了 VIVERSE 願景，發表 HTC 包羅萬象的產品策略，未來各項創新融合將應用於 VIVERSE 世界中!