• 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.