Boston Scientific Lead Engineer S/W QA 

India, Maharashtra, Pune 

751450699

India-Maharashtra, Pune

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.