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.
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).
