Offer summary

Qualifications:

Experience in Verification & Validation activities for Medical/Health products throughout the entire design cycle., Knowledge of standards like IEC60601-1-2, ISO 80601-2-13, ISO 18562, and ISO 10993., Hands-on experience preparing verification protocols, executing tests, and analyzing results., Proficiency with tools such as JIRA, ClearQuest, HP ALM, and requirement management software..

Key responsibilities:

Conduct verification and validation activities for medical devices from design to production.

Collaborate with external labs to ensure compliance with standards and manage testing processes.

Identify and log issues during verification, facilitate defect resolution, and review with cross-functional teams.

Drive reliability assessments and demonstrate product reliability for hardware and software components.

Job description

Mandatory :

Hands experience in Verification & Validation activities for MedicalHealth products from beginning of NPINPD (Complete design life cycle)

Good in Analyze requirements, assess early are these requirements are testable or not. Assess if any fixtures or equipments required in advance.

Hands experience in preparing System verification producesprotocol, execute tests and product test results & reports.

Have Knowledge on standards like IEC6060112 (EMIEMC), ISO 80601213, Biocompatibility standards ISO 18562 & ISO 10993. Capable to guide and execute the standards testing with External labs like TUV UL Intertek and mitigate the issues.

Having experience in detailed discussion with external labstesting agencies to enquire Lab facility required, certifications for the Medical devices and select & Manage testing.

Drive team to 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.

Have hands on experience on Reliability assessment and demonstration reliability for hardware & software.

Working experience in Ventilator or Anesthesia or Dialysis machine products will be an advantage. Hands experience in Verification & Validation activities for MedicalHealth products from beginning of NPINPD (Complete design life cycle)

Good in Analyze requirements, assess early are these requirements are testable or not. Assess if any fixtures or equipments required in advance.

Hands experience in preparing System verification producesprotocol, execute tests and product test results & reports.

Having experience in detailed discussion with external labstesting agencies to enquire Lab facility required, certifications for the Medical devices and select & Manage testing.

Drive team to 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.

Have hands on experience on Reliability assessment and demonstration reliability for hardware & software.

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