Senior Manager, System Engineering - Singapore - BIOFOURMIS SINGAPORE PTE. LTD.

Description

• Support systems engineering efforts for complex, data-science driven, turnkey medical solutions that span hardware devices, mobile phone apps, and cloud backend; responsibilities for supporting and reporting on all phases of the product development and operations lifecycle including hardware assembly and integration, software builds, releases and updates, configuration control, requirements, design, and test execution.
• Collaborate with a diverse technical team to lead the creation, update, and maintainance of documentation that is or will become part of the product design history file (DHF) for medical therapeutics solutions.
• Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed using tools such as Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities when applicable.
• Facilitate transparent communication between teams and stakeholders, providing regular project updates and metrics addressing any technical or scheduling challenges.
• 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.
• Provide input for submissions to regulatory bodies and governmental agencies.
• Works with the RA/QA team to ensure product and procedural compliance to regulatory standards.
• Respond rapidly and flexibly to emerging issues in production, quality, and engineering.
• Manage a comprehensive solution for capturing requirements, traceability, verification and validation testing suite
• Identify, champion and drive formal and informal process improvement efforts.
• Own and lead execution and closure of CAPAs and NCRs
• Works closely with the VP of Systems Engineering to identify and drive toward team-wide metrics
• Cultivate a culture of continuous improvement by staying informed about industry trends technological advancements, and emerging tools in medical device systems engineering, human factors, design controls, reliability testing, and software development.
• Build and mentor a team of systems engineers to ensure that engineering and quality processes are implemented effectively and consistently across all products.
• Actively participate in attracting, selecting, retention, and developing the team.