Engineer II, GPE
2 weeks ago
Additional Locations: India-Haryana, Gurgaon
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.
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 maintain the project documentation in online RM tool throughout all phases of NPD and Sustaining.
- Investigate and evaluate the compliance requirements driven from organizations QMS/Work Instructions and validate the same in templates developed in RM tool.
- Investigate and evaluate existing RM tools/technologies JAMA, Polarion etc.
- Investigate compliance gaps in project documents and resolve them with project stakeholders.
- Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents.
- Perform 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 4 years of experience.
- Preferred experience in management of DHF documentation during the 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.
Requisition ID: 593130
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal. And if youre a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
Locations: Gurgaon, HR, IN
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