Job Description

Additional Location(s): India-Haryana, GurgaonDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 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.

Requisition ID: 587063As 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!At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code \xc2\xa7 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.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.

Boston Scientific