R&D Verification & Validation Engineer | Loyang

Job Responsibilities

• Develop and execute test plans and protocols for design verification, process characterization, process validation, finished products, and benchmarking studies.
• Manage the R&D prototype and testing laboratory, including equipment, tools, and budget planning.
• Maintain testing equipment and ensure timely calibration and qualification.
• Design, develop, and implement automated and manual test procedures for functional, performance, and regression testing.
• Identify and consolidate product performance, functional, and regulatory testing requirements.
• Lead design verification and validation activities to ensure compliance with applicable IEC, FDA, GMP, ISO, and other regulatory standards.
• Conduct benchmarking tests to evaluate product quality and performance against existing products.
• Develop and validate testing equipment, fixtures, and test setups for various applications.
• Conduct feasibility testing in collaboration with Product Development and Quality teams.
• Liaise with external testing laboratories and equipment vendors to obtain required testing data and identify suitable test equipment.
• Identify, document, and track defects using appropriate issue-tracking tools.
• Work closely with development teams to identify and resolve potential product and testing issues early in the development lifecycle.
• Communicate identified risks and testing concerns to the Test/Team Lead.
• Prepare and present test reports and findings to project and management teams.
• Perform other duties and projects as assigned by the supervisor.

Job Requirements

• Degree in Mechanical Engineering, Electrical Engineering, Materials Science, Biomedical Engineering, Bioengineering, or a related discipline will be bonus.
• 3 years of relevant experience in R&D testing, product verification/validation, or a related engineering environment.
• Experience in Medical Device, Automotive, Aerospace, or other highly regulated industries is preferred.
• 1 years of experience in design verification and validation, preferably within the Medical Device or other highly regulated industries.
• Strong knowledge of test and design verification methodologies, regulatory requirements, and related documentation.
• Good understanding of Design of Experiments (DOE) principles.
• Proficiency in Minitab or other statistical analysis software.
• Strong problem-solving, troubleshooting, and debugging skills.
• Experience with test automation tools and scripting languages.
• Good understanding of cybersecurity requirements related to medical device testing.
• Strong time management and ability to prioritize tasks and meet deadlines.
• Excellent communication and stakeholder management skills, with the ability to work effectively across Product Development, Quality, Regulatory, and other technical teams.

Interested candidates are invited to apply via the “Apply Now” button.

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EA Personnel: Ching Ning Xin
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