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
5 - 10 Years
5 Openings
Not Disclosed
Vashi Mumbai 
Face-to-Face interview
Similar Jobs
Higher Boosting
Resume Highlighter
Verified Stamp
Resume Exposure
