Software Engineer
About us:
Mediwhale is a pioneering AI healthcare startup focusing on predicting cardiovascular, renal, and metabolic disease (CVRM) risks using retinal biomarkers. The eye is the only organ where blood vessels are directly visible without invasive procedures, which is our key to unlocking unprecedented insights into human health.
At Mediwhale, the Regulatory Affairs Specialist collaborates with health authorities to establish and manage device registrations and regulatory strategies, ensuring regulatory approval and ongoing compliance for medical devices both domestically and internationally. This role is crucial in supporting essential regulatory processes for the launch of new products and the quality assurance of existing products.
SaMD Team:
Mediwhale’s development organization is structured into four teams: AI, SaMD, Solution, and Information Security. Among them, the SaMD Team plays a central role in developing Software as a Medical Device (SaMD).
SaMD products require a wide range of capabilities, including diagnostic functions, patient data management, authentication and security, report generation, and license management. In addition, they must address regulatory requirements for medical devices, operational needs from the Sales team, and field feedback from the Solution team, bringing together the demands of multiple stakeholders.
The mission of the SaMD Team is to develop safe software that meets these complex requirements while minimizing risks. Achieving this mission is not just about working hard—it requires designing appropriate systems, actively adopting automation and tools to reduce human error, and creating a sustainable development environment.
To achieve these goals together, we are looking for individuals who are not limited to a specific technology, but who demonstrate flexible thinking, curiosity for new technologies, and a sense of responsibility in applying their skills. The SaMD Team is committed to building an environment where such talent can fully immerse themselves and thrive.
Responsibilities:
- Design and develop SaMD (Software as a Medical Device) products based on business, user, and regulatory requirements.
- Write testable code and implement test cases to ensure safe products.
- Collaborate with the AI Team to deploy and manage AI models.
- Work with the Solution Team to support problem-solving in the field.
- Analyze operational issues and provide solutions tailored to user needs.
- Build internal tools, systems, and guidelines to improve the development environment.
- Develop admin pages and dashboards to enhance the operational environment.
- Create and maintain technical documentation for products.
Qualifications:
- 5+ years of backend development experience
- 3+ years of Python development experience, or equivalent knowledge
- 3+ years of RDBMS experience, or equivalent knowledge
- Solid foundation in computer science fundamentals
- Openness to new technologies, with curiosity and a strong desire to learn
Note: The above experience and knowledge do not need to come solely from corporate environments. Contributions to personal projects, open-source initiatives, or self-directed learning are also valued.
Preferred:
- Understanding of SaMD (Software as a Medical Device)
- Experience with healthcare/medical data (DICOM, EMR, PACS, HL7, etc.)
- Knowledge of medical device software standards such as IEC 62304
- Experience with cloud infrastructure
Benefits:
- Flexible working conditions (flexible hours and remote work up to 2 days a week)
- Remote work policies may change based on company circumstances or policies
- Lunch stipend (regardless of work location), coffee, beverages, and snacks provided
- Annual comprehensive health check-up
- Additional leave in addition to statutory annual leave (e.g., vaccination leave, birthday leave, family events)
- Support for job-related books and professional courses
Application Process:
- Application Screening → 1st Interview → 2nd Interview → Final Offer
- Tasks may be assigned according to the role, and the interview process may be subject to change.
- Depending on the role, an assignment may be given, and interview procedures may be adjusted.
- Application materials: Open format (must include resume)
- Please highlight your previous roles and specific contributions.
- Job interview: Approximately 2 hours, focusing on past experiences and technical knowledge.