Engineer II, GPE

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll 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 Responsiblities:

• 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.
• Investigates and evaluates the compliance requirements driven from organization’s QMS/Work Instructions and validates 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 stakeholders.
• 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
• Draft technical documentation based on RM tool usage (guidance documents)

Minimum Qualificaiton:

• Mechanical Engineering (B.E./B. Tech) with 6-8 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
• Strong attention to detail with good communication skills.
• Nice to have experience in technical writing
• 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: 622663

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) isn’t just business, it’s personal. And if you’re 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!