R&D Test Engineer

2 weeks ago

East Region, Singapore Fong's Engineering & Manufacturing Pte Ltd Full time $90,000 - $120,000 per year
  • Develops and conducts test plans and protocols for design verification, process characterization, process validation, finished product and benchmarking study to generate test reports with engineering principle.
  • Manage R&D prototype and testing lab, participate prototype & testing lab budget management.
  • Maintain the equipments and tools and monitor regular required calibration, qualification.
  • Design, develop, and implement automated and manual test procedures for functional, performance, and regression testing.
  • Identifies and consolidates requirement lists from product performance, functional and regulatory aspects
  • Drives the entire design verification and validation activities to ensure compliance to regulatory requirements such as IEC, FDA, GMP, ISO and IEC standards.
  • Develops and executes various benchmark testing to understand product quality compared to existing products
  • Develops and validates new equipment and fixtures to conduct various testing.
  • Conducts feasibility testing together with product development and quality team
  • Liaise with external test labs to obtain critical data for test reports.
  • Work with equipment vendors to identify test equipment that meets testing requirements.
  • Identify, document, and track defects using issue tracking tools.
  • Work closely with development teams to identify and address potential issues early in the development lifecycle
  • Communicate all identified risks to your Test/Team Lead
  • Summarizes test report and present to project and management team.
  • Perform other tasks as assigned by the supervisor.

Education

  • Degree or Master in Mechanical Engineering, Electrical or Material Science / Bio Engineering or related field

Experience

  • Minimum 3-5 years relevant experience, preferably in Medical Device, Automotive or Aerospace industry.
  • Preferably 1-2 years of relevant experience in design verification and validation of Medical Device or other highly regulated industries

Skills

  • In-depth knowledge of test and design verification methodologies, regulatory standards/environment requirements and required documentations.
  • Good understanding of DOE (Design of Experiments) principles.
  • Good command of Minitab or other statistical analysis software
  • Excellent problem-solving and debugging skills.
  • Proficiency in test automation tools and scripting languages
  • Have good understanding of cybersecurity requirements for medical device testing.
  • Good time management skills, including the ability to prioritize work and meet deadlines.
  • Strong interdisciplinary communication skills with internal and external stakeholders (customers, project, development, quality, and regulatory teams).

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