Additional Locations:India:Haryana, Gurgaon Diversity : Innovation : Caring : Global Collaboration : Winning Spirit : High Performance At 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. Purpose Statement: Responsible for providing Quality Engineering Input to support Manufacturing, Manufacturing Engineering, and R and D activities that involve the development or use of software products. Key Responsibilities: stylemargin:bottom:13.0px: : 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 and D quality engineering, systems and / or quality engineering supporting R and 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. Requisition ID:602955 As 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 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 and look forward to connecting with you