R&D Test Engineer

FONG'S ENGINEERING AND MANUFACTURING PTE LTD; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading engineering firm in Singapore is seeking a qualified individual to manage test plans and design verification for regulatory compliance in medical devices and other industries. The role requires a degree in engineering and 3-5 years of relevant experience, with skills in test methodologies and excellent communication abilities.

Qualifications

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

Responsibilities

• Develop test plans and generate test reports.
• Manage R&D prototype and testing lab budget.
• Maintain equipment calibration and qualification.
• Implement automated and manual test procedures.
• Drive design verification and validation activities.

Skills

Knowledge of test and design verification methodologies

Understanding of DOE principles

Command of Minitab or statistical analysis software

Problem-solving and debugging skills

Proficiency in test automation tools

Understanding of cybersecurity requirements for medical devices

Time management skills

Communication skills

Education

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

Job description

• 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).