Senior Design Verification Engineer (Medical Device Product & Regulatory Requirements)

5-8 years
3 days ago
Job Description

  • 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 Singapore R&D Team 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.

  • Masters or Bachelor's degree in Mechatronics, Electrical & Electronics or Computer Engineering with 5 years of relevant experience in design verification and validation of Medical Device, Applied Device or Surgical Microscopy products.
  • 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,
  • Excellent analytical and troubleshooting skills,
  • A good eye for details, advance verbal, and written communication skills,
  • Good awareness of emerging trends in the medical device regulatory environment, and
  • 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



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