R&D Test Engineer

• 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).