Boston Scientific Engineer III GPE 

India, Haryana, Gurugram 

145935830

India-Haryana, Gurgaon

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).

Key Responsibilities:

• 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

Qualifications:

• 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.

• Willingness to work in an agile environment.