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Boston Scientific Senior Engineer S/W QA 
India, Haryana, Gurugram 
928206653

14.04.2025

India-Haryana, Gurgaon

Purpose Statement:

Responsible for providing Quality Engineering Input to support Manufacturing, Manufacturing Engineering, and R&D activities that involve the development or use of software products.

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.
  • Actively participates in New Product Development, Design Review, and Design Control Activities, as related to software products.
  • Develops and implements Process and Product Software Verification and Validation activities with reference to external standards and regulations, such as FDA, ISO, IEEE.
  • Leads the activities associated with the Software products risk assessment.
  • Provides technical guidance and training to other Department members in Software QA Engineering areas of expertise.
  • Controls and maintains the database for tracking defects associated with the products during the design life cycle.
  • Provides input to, defines and approves Product and Process Validations and Reports.
  • Establishes requirements for Installation and Operational Qualifications for new and replacement equipment.

Requirements:

  • Bachelors (or higher) degree in engineering with preference Computer Science.
  • 9+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation.
  • Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
  • Sound understanding of medical device regulatory requirements for Class II and III medical devices.
  • Project planning – resourcing, timelines, quality and budgets.
  • Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
  • Preference for candidates with CQE certification or similar training and experience
  • Proficient in project management tools like MS project.
  • Experience in ISO 62304.