Verification & Validation Engineer Jobs

Key ResponsibilitiesAssist in qualification and validation activities including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).Prepare, review, and maintain validation protocols, reports, and supporting documentation.Execute validation tests and document results accurately.Support process, cleaning, equipment, utility, and computerized system validation activities.Ensure compliance with GMP, GDP, and applicable regulatory requirements.Participate in risk assessments, deviation investigations, and corrective/preventive action (CAPA) activities.Analyze validation data and prepare summary reports.Coordinate with Quality Assurance, Production, Engineering, and Maintenance teams.Maintain validation schedules and support periodic review activities.Assist during internal and external audits related to validation activities.

Apply only immediate Joiner and having exp in medical device's.RequirementBachelor 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 13485, and IEC 60601 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 13485, IEC 62304, IEC 60601, and ISO 14971 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 (i.e. Doors, Jama, Test Track, etc.) Familiarity with main standards applicable to the development of medical devices (i.e. IEC 60601-1, ISO 10993, 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 (e.g. 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

Design and Develop Embedded Software (Low Level Driver) for multicore Controller, Safety and Security modules Analyze Software and System Requirements in line with AUTOSAR Spec Participation in customer meetings for requirement clarification Derive Verification and Validation criteria for Requirements Derive the simulation software requirements based on the validation scope and approach Configure base Software components in accordance with customer specific requirement AUTOSAR sw component integration and RTE Configurations Perform SW Safety Analysis as per ISO26262 Support in task estimations, technical reviews, technical clarifications, problem analysis discussions Willing to travel to customer site @Europe on business need