- Support software engineering efforts for a complex, data-science driven, turnkey medical solution that spans a hardware device, mobile phone apps, and cloud backend
- Supporting and reporting on all phases of the product development and operations lifecycle including hardware assembly and integration, software builds, loads and updates, configuration control, requirements, design, and test execution.
- Collaborate with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a medical therapeutics solution.
- Support the development and maintenance of product specifications, requirements documents, hazards analysis documents, usability and Validation and Verfication documentation, and other technical documentation.
- Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.
- Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
- Work with subsystem teams and domain subject matter experts in the identification, logging, assessment, and resolution of integration and test issues.
- Provide technical guidance for product design, development, integration, testing, and reliability improvements.
- Owns and drives resolution of design issues/defects.
- Works with QA team to specify and document product tests for compliance to regulatory standards.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Respond rapidly and flexibly to emerging issues in production, quality, and engineering.
- Create and review process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.
- BS in Software Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field).
- Minimum 1 year experience working as a Software Engineer on product design, development, and/or testing; experience with medical device product will be good.
- Understanding of medical device product design and regulatory processes.
- Experience with medical device software design and development processes that conform to standards
- Good understanding of cloud solutions, mobile apps, medical devices.
- Technical understanding of and experience with best-practice product development methodologies.
Octavius, Whei Jie Yong EA License No.: 02C3423 Personnel Registration No.: R1110096