Job Description

• Lead a team to contribute and support design verification through automated testing and technical test support activities of new market-leading microscopy products.
• Design and develop test firmware/software to realize new solutions with overall responsibility for the delivery and quality of the new solutions
• 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\xe2\x80\x99 functionality work as intended with all the verification results clearly documented within the official verification report and review documents..
• 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 Singapore R&D Team has fulfilled the required standard before transferring to production.
• 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 Bachelor\xe2\x80\x99s degree in Mechatronics, Electrical & Electronics or Computer Engineering with 7 years of relevant experience in design verification and validation of medical devices.
• In-depth knowledge of automation test and design verification methodologies, required documentations, and regulatory requirements
• In-depth knowledge of complex embedded software/firmware development on Linux, RTOS or embedded Windows platform
• Experience and knowledgeable in mechanical, electronic hardware, firmware, and software for developing verification and automated test solution.
• Experience in bringing new medical device/equipment through the verification and validation process to market introduction
• Knowledge of industrial manufacturing procedures
• Excellent analytical and troubleshooting skills.
• Good awareness of emerging trends in the medical device regulatory environment & embedded software industry
• Good knowledge of general and medical device/equipment regulatory standards & requirements.

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Tan Wai Peng | Registration No: R1104671

GMP