Perform design verification & validation of new products for medical and other mission-critical systems.
Analyze the products and design specifications to create reliable and thorough verification procedures to determine if the products’ functionality work as intended with all the verification results clearly documented within the official verification report.
Responsible for the entire design verification and validation process to ensure compliance to regulatory requirements including relevant EMI/EMC, FDA, GMP, ISO, IEC standards.
Assume overall responsibility for ensuring the design quality of all new products designed by company R&D has fulfilled the required standard before transferring to the Operation Team.
Oversee the continuous improvement in the design verification and validation processes to keep pace with changes in the regulatory environment.
Comply and adhere to company Quality Management System and Environment, Health & Safety requirements.
Requirements
Masters or good Bachelor’s degree in Mechatronics, Electrical & Electronics or Computer Engineering with 5 years of relevant experience in design verification and validation of medical devices.
Must have background experiences in Medical Device or Applied Device Industries.
Good to have deep knowledge in Surgical Microscopy.
Strong interdisciplinary communication skills (customer, PM, R&D, RAQA, internal and external supplier)
In-depth knowledge of test and design verification methodologies, regulatory requirements and required documentations,
Experience in bringing new medical device/equipment through the verification and validation process to market introduction,
Knowledge of industrial manufacturing procedures,
Good awareness of emerging trends in the medical device regulatory environment, regulatory standards and requirements.
GMP Technologies (S) Pte Ltd | EA Licence 11C3793 | EA Personnel: Novita Widjaja | Registration No: R22105960
