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Stryker
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Software Engineer

Software Engineer

Stryker

5 years

0 Lacs

gurugram haryana india

Posted:1 week ago| Platform:

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Skills Required

software design test data mobile tracking testing regression integration planning strategies risk assessment reports traceability training documentation engineering management jira devops development certifications integrity remediation cybersecurity reporting communication healthcare

Work Mode

On-site

Job Type

Full Time

Job Description

What you will do:

Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira).
Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups
Develop and execute validation strategies and plans for new and existing computerized systems.
Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceability Matrix.
Perform impact assessments and change control activities for validated systems.
Provide training and guidance on CSV processes and best practices.
Maintain validation documentation in alignment with company procedures and regulatory expectations.

What You Will Need-

Required:

Experience- 2yrs to 5 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices).
Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
Good understanding of SDLC, and defect life cycle; Experience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.

Preferred :

Understanding of software development life cycle (SDLC) and risk-based validation approaches; CSV certifications (e.g., ISPE, PDA) or GxP training; ISTQB Certification
Experience in data integrity assessments and remediation projects; Familiarity with cloud-based systems and cybersecurity considerations.
Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
Excellent documentation, reporting, communication, and project management skills.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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Stryker

Medical Technology

Kalamazoo

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Software Engineer