My client is a world leader in the medical software and equipment industry and is expanding in Singapore.
This Senior Systems Lead will play a critical role in supporting the design, development, testing, and documentation of our solutions. This individual will support systems engineering related activities on product development programs
- Support systems engineering efforts for a complex, data-science driven, turnkey medical solution that spans a hardware device, mobile phone apps, and cloud backend
- Report 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 V&V 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.
- Works with QA team to specify and document product tests for compliance to regulatory standards.
- 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.
- Manage and automate Jira/Confluence.
- Design and approve automated processes for product development.
- Design and approve risk analysis, risk manage, Verification and Validation procedures.
- Advanced Degree in Systems engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); Masters preferred.
- Prior experience as a Systems/Software Engineer working on product design, development, and/or testing; experience with class II medical device products
- Understanding of medical device product design and regulatory processes.
- Stronghold with JIRA and Confluence
- Proficient with Scrum/Agile Methodology
- Able to communicate effectively, both verbally and in writing.
- Experience with medical device design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
- Strong understanding of cloud solutions, mobile apps, medical devices.
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).