Senior Verification & Validation Engineer
Nitto Denko Asia Technical Centre Pte. Ltd.| Date Posted: 30-Jul-2020
Bachelor's / Honours
DUTIES & RESPONSIBILITIES:
- Develop Design Verification and Validation plan for new product design and development
- Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
- Develop and execute Verification and Validation protocols that effectively challenges product design and based on System and Sub-system requirements.
- Develop and conduct sampling procedures and statistical analysis on test data
- Identify and investigate root cause of test anomalies and failures, raise and resolve issue logs.
- Document test results and generate verification and validation records and reports.
- Drive the development and construction of test equipment, jigs or fixtures whenever needed.
- Work closely with different functions, e.g. System, Mechanical and Electrical Engineers, QA, RA and Operation team.
- Review Design Input and Output documents. Provide inputs to the design requirements for clear, concise and testability.
- Ensure the design considerations are embedding all applicable DFX (design for Excellence) aspects including manufacturability, usability, reliability and safety.
- Liaise with external test labs or suppliers for conducting verification/validation tests.
- Involve in quality control activities (including, but not limited to, FMEA, Hazard Analysis etc.)
- Participate in Design Reviews and giving inputs to development team.
- Understand the NCE, CAPA and Change Management.
- Summarize data using appropriate descriptive and inferential statistics. Collate, analyze and interpret statistical data for internal and external customers
- Properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements.
POSITION & QUALIFICATION REQUIREMENTS:
- Bachelor of engineering with 3 - 7 years of experience in Medical Devices Industry
- Medical Devices/Life Science Industry experience along with the In depth knowledge in FDA / ISO requirements- such as ISO 13485/IEC 62304/ISO 14971/IEC 62366 and FDA part 820.
- Experience in medical device verification, validation, human factor/usability tests. IVD device experience is preferred.
- Experience with conventional inspection and measurement equipment
- Analytical ability in problem solving
- Good communication skills, interpersonal skills, team work.
- Ability to work under pressure and time constraints
Interested candidates please apply via the Apply Now button.
We regret that only shortlisted candidates will be notified.
Nitto Denko Asia Technical Centre Pte. Ltd.