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