Offer summary

Qualifications:

Hands-on experience in software verification for medical products throughout the design life cycle., Proficient in writing verification plans, protocols, and generating test results/reports., Knowledge of IEC60601-1-8 standards and experience with pre-compliance testing., Familiarity with software development life cycle processes as per IEC 62304 and ISO 14971..

Key responsibilities:

Analyze requirements to determine their testability and document findings.

Write and execute verification plans and protocols, and generate test results.

Log issues in tools like JIRA or ClearQuest and collaborate with cross-functional teams for resolution.

Work with internal and external teams to implement best practices in software verification.

Job description

Mandatory :

- Hands experience in Verification of Software for Medical/Health products from beginning of NPI/NPD (Complete design life cycle)

- Good in Analyze requirements, assess early are these requirements are testable or not.

- Must have hands on experience in writing Verification plan, verification protocols, testing and generating Verification test results/reports.

- Have hands on experience on standards like IEC60601-1-8, review the applicable requirements and hands experience in execute pre-compliance and formal complicable tests with internal team and external labs.

- Have good knowledge on Software Development life cycle process as per IEC 62304 and ISO 14971

- Identify issues from verification, log the issues in tools like JIRA or ClearQuest, Drive defect control board, review with crossfunctional team and verify the resolutions.

- Must have experience in verification of Embedded firmware/software.

- Have Experience in Software reliability demonstration and Automation testing.

- Have collaboration with Internal team and external team to bring best practices.

- Working experience in Ventilator or Anesthesia or Dialysis machine products will be an advantage.

Specific Software/ IT Knowledge require:

DOORs, JIRA, ClearQuest, HP ALM, Any PLM tools, Requirement management tools

Preferred Companies/ Industries:

Health care or Medical equipment - Verification & Validation

Required profile