Boston Scientific Engineer II S/W QA 

India, Haryana, Gurugram 

511138114

India-Haryana, Gurgaon

The primary responsibility of this position is to work within a team of Software Quality Assurance, Software Developers and Test Engineers (embedded with R&D), actively contributing to all aspects of Software Quality Assurance responsibilities, involving software/hardware/firmware used in all of the Boston Scientific product lines. These responsibilities include Verification and Validation activities, which encompass requirements review, code and design reviews, risk management, system level (black box), structural (white box) and test automation activities.

Key Responsibilities:

• Develops, applies, revises, and maintains quality standards for software products that the company develops as part of finished products or in support of manufacturing, manufacturing engineering, or quality processes.
• Monitors project team compliance to applicable quality procedures and standards by auditing project deliverables such as requirements documents, test results, etc.
• Actively participates in New Product Development, Design Review, and Design Control Activities, as related to software products.
• Analyzes project metrics by determining significant measures for projects and working with project teams to gather the necessary data.
• Controls and maintains the database for tracking defects associated with the products during the design life cycle.
• Leads & supports the activities associated with the Software product's risk assessment.
• Coordinates software validation activities by working with project teams and corporate compliance groups to assure systems are properly validated. Provides input to, defines and approves Product Validations and Reports.
• Consults with project teams to provide information on quality best practices by meeting with project teams for formal training or informal discussion.
• Provides technical guidance and training to other Department members in Software QA Engineering areas of expertise.

Qualifications and Skill-Set:

• B.E./B. Tech in CS or equivalent to IT. MCA/M. Tech in software AI/ML/Software Related
• 5–10 Years of experience required for this role.
• Certification in CSQE (Optional)
• Experience in Software Design Validation and Verification
• Experience in Risk Management
• Experience in Class II and Class III medical device preferred.
• Good to have Domain knowledge /Digital Health
• Strong background software quality – ISO 62304, 13485, 14971, 21 CFR Part 820
• Good to have knowledge in Cybersecurity/Digital Health Knowledge
• Basic Understanding of Software Process Knowledge, Design Control