Job Description

Additional Locations: India-Maharashtra, PuneDiversity - 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.Provide Software Quality Assurance leadership at the Marlborough site. Develops, modifies, applies and maintains standards for Software Quality methods, processes and procedures which meet Boston Scientific and external regulatory requirements and implements against them. Establish a method for monitoring the compliance of software system processes, standards and procedures. Provides expertise on software validation requirements to project teams that are implementing software systems and provides independent review to teams. Teaches and coaches less experienced colleagues and manages Equipment and Automated Systems (E&AS) program.Key Responsibilities:

• Demonstrate mastery of Boston Scientific rigorous Software Development Lifecycle (SDLC).
• Ensure that systems are developed and supported in accordance with the SDLC and applicable FDA regulations.
• Provide insight and expertise on software quality practices throughout the SDLC.
• Lead and participate in the development and creation of: Software Quality plans; Validation plans; Risk analyses; Test plans; Test scripts; Requirements-Design-Test Traceability analyses.
• Lead and coordinate day-to-day activities of Legacy Software Remediation.
• Lead and provide over-site for the Equipment and Automated Software Program.
• Works with software managers to understand priorities and plans/provides input to resource and time allocation accordingly.
• Plays a key role in providing full guidance and direction on acceptability of Software Quality deliverables, based on requirements and templates given.
• Acts as an effective team member who provides review on deliverables used to develop, implement and maintain quality software.
• Proactive involvement in continuous improvement activities for the software Quality life cycle while ensuring Boston Scientific\'s software systems meet regulatory requirements

Key Qualification:

• B.E./B.Tech in CS or equivalent to IT. MCA/M.Tech in software AI/ML/Software Related
• Certification in CSQE (Optional)
• Must have Software Design Validation and Verification.
• Experience in Risk Management is required.
• Experience in Class II and Class III medical device preferred.
• Domain knowledge /Digital Health - Optional
• Strong background software quality - ISO 62304, 13485, 14971, 21 CFR Part 820 - Must
• Cyber Security/Digital Health Knowledge (Good to have)
• Candidate must have experience in basic Understanding of Software Process Knowledge, Design Control
• 10-12 Years of experience required.

Requisition ID: 582712As 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!

Boston Scientific