Product Engineer (Software as Medical Devices/Wearables)

Location Singapore
Job reference BBBH103486_1632205870
Salary S$3500 - S$6000 per annum + AWS + VB
Consultant email wheijie.yong@experis.com.sg
EA License No. 02C3423


Responsibilities:

  • 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.

Requirements

  • 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

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