Boston Scientific Engineer II GPE R&D 

India, Haryana, Gurugram 

647085727

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 7+ years of Exp.
• 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.