- Support systems engineering efforts for a complex, data-science driven, turnkey medical solution that spans a hardware device, mobile phone apps, and cloud backend; responsibilities 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 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.
- 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.
- Manage and automate Jira/Confluence
- Write and Review documentations for QMS
- Design and approve automated processes for product development
- Design and approve risk analysis, risk manage, Verification and Validation procedures
- 1+ years experience working as a Systems Engineer on product design, development, and/or testing; experience with class II medical device products good to have.
- Understanding of medical device product design and regulatory processes.
- Experience with medical device design and development processes that conform to standards
- Understanding of cloud solutions, mobile apps, medical devices.
- Technical understanding of and experience with best-practice product development methodologies.
- BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering
- Experience (1+ years) with Jira and Confluence
- Proficiency with Scrum/Agile methodology
Arvin Clark Sikat, Sombilla EA License No.: 02C3423 Personnel Registration No.: R1222536