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Senior Software Engineer - CSV

Stryker is a leading global medical technology company.
Backend
Senior Software Engineer
Hybrid
5,000+ Employees
5+ years of experience
Healthcare

Job Description

Stryker is seeking a Senior Software Engineer specializing in Computer Systems Validation (CSV) to join their team in Gurugram, India. This is a hybrid role perfect for analytical problem solvers and dedicated achievers who thrive in a fast-paced medical technology environment. The position focuses on ensuring software systems meet FDA regulations and quality standards.

The role combines technical expertise with quality assurance, requiring deep knowledge of validation processes and medical device regulations. You'll be responsible for creating and maintaining validation documentation, coordinating with cross-functional teams, and ensuring compliance with FDA requirements. The ideal candidate brings 5-8 years of experience and strong technical abilities, particularly in quality principles and computer system development lifecycles.

This position offers an opportunity to work with cutting-edge medical technology while ensuring patient safety through robust validation processes. You'll be part of a global leader in medical technology, working on critical systems that impact healthcare delivery. The role requires no travel and offers a hybrid work arrangement, providing flexibility while maintaining collaborative opportunities.

Key aspects of the role include authoring validation plans, coordinating with various teams, managing equipment qualification efforts, and providing training on computer validation. You'll need excellent documentation skills, attention to detail, and the ability to work independently while collaborating effectively with multiple stakeholders.

This is an excellent opportunity for someone passionate about combining software engineering with quality assurance in the medical device industry. The position offers the chance to work on meaningful projects that directly impact patient care while being part of a leading global medical technology company.

Last updated 2 days ago

Responsibilities For Senior Software Engineer - CSV

  • Author, Review, and Approve CSV deliverables Validation Project Plan
  • Follow Computer Systems Validation processes
  • Take ownership of CSV and Equipment Qualification effort
  • Coordinate with different teams for understanding requirements
  • Review and identify validation deviations
  • Work with QA/Design/Test teams
  • Create and provide computer validation training programs
  • Assess risks related to systems
  • Follow SOPs to help business process in line with FDA regulations
  • Maintain and review validation documentation
  • Train staff on computerized systems

Requirements For Senior Software Engineer - CSV

  • Technical ability with knowledge of quality principles (ISO 13485)
  • Knowledge of computer system development lifecycles
  • Keen attention to detail with natural curiosity and learning agility
  • Good communication skills
  • Excellent organizational ability
  • Familiarity with Medical standards & FDA requirements
  • Basic Knowledge of any Programming language
  • Excellent documentation and Written/Verbal communication skills
  • Must be flexible, independent, and self-motivated
  • 5-8 years of experience

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