Apply only immediate Joiner and having exp in medical device's.
Requirement
Bachelor of Science degree in Engineering
5+ years experience in conducting verification and validation of electro/mechanical systems in a regulated industry.
Medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO , and IEC is highly preferred
Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls Experience with design and development processes that conform to standards such as ISO 9000, ISO , IEC , IEC , and ISO
Possess the ability to analyze requirements and develop a risk-based approach to testing
Familiarity with measurement equipment, preferably including mass flow controllers and other pneumatic elements
Familiarity with requirement management tools leading to generation of complete traceability matrices (. Doors, Jama, Test Track, etc.) Familiarity with main standards applicable to the development of medical devices (. IEC -1, ISO , etc.)
Knowledge of statistical techniques for experimental design and data analyses
Strong design control and documentation skills
Good technical writing skills, including development of test methods, protocols, reports Proficient computer skills with applicable software packages (. Microsoft Office, Microsoft Project, Microsoft Power Point, etc.) and test data analysis software packages (JMP, Minitab, ReliaSoft, and/or Python)
Good communication skills
Able to learn new technologies
Able to work independently and in a team environment
Experience with respiratory equipment is a plus
Excellent problem-solving skills