Engineer III, GPE

Responsible for providing mechanical engineering support in the maintenance of project DHF deliverables in Requirements Management (RM) tool for new and sustaining medical device products (invasive and non-invasive). Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining. Investigates and evaluates the compliance requirements driven from organization's QMS/Work Instructions and validate the same in templates developed in RM tool. Investigates and evaluates existing RM tools/technologies - JAMA, Polarion etc. Investigates compliance gaps in project documents and resolve them with project stake holders. Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents. Performs validation of patches and versions of RM tool as and when available. Support multiple projects across different time zones - Asia, Ireland, and North America Mechanical Engineering ( B.E./B.Tech) with 8-10 years of experience. Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971 Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit. Knowledge of MS Office Tools - Word, Excel, PowerPoint. Strong attention to detail with good communication skills. Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making. Ability to collaborate and work as a team player. Nice to have experience in product lifecycle management software and tools.