Boston Scientific Senior Engineer S/W QA 

India, Haryana, Gurugram 

928206653

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.