Senior Systems Lead (Medical Software and Devices)

Location: Singapore
Job Type: Permanent
Specialisation: Engineering & Manufacturing
Salary: S$6000 - S$8500 per month
Reference: BBBH8391_1599716363
Contact: Abhik Damani
Email: email Abhik

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

Responsibilities:

  • 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.

Requirements:

  • 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).