Software Engineer at Stryker

Gurugram, Haryana, India

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Pharmaceuticals, BiotechnologyIndustries

Requirements

2-5 years of experience in manual software testing and computer system validation (CSV) 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)
Experience validating systems such as Valgenesis and custom applications
Preferred Requirements
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

Responsibilities

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

Skills

Manual Testing

Jira

Computer System Validation

GAMP 5

21 CFR Part 11

Annex 11

SDLC

Functional Testing

Regression Testing

Integration Testing

System Testing

Valgenesis

DevOps

ISTQB

IQ/OQ/PQ

Traceability Matrix

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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