Offer summary

Qualifications:

Hands-on experience in Verification & Validation for Medical/Health products throughout the design life cycle., Knowledge of standards such as IEC60601-1-2, ISO 80601-2-13, and biocompatibility standards ISO 18562 & ISO 10993., Experience with tools like JIRA, ClearQuest, and DOORs for issue tracking and requirements management., Familiarity with reliability assessment for hardware and software, preferably in ventilator or anesthesia products..

Key responsibilities:

Conduct Verification & Validation activities for medical products from NPI/NPD stages.

Analyze requirements to determine testability and assess necessary fixtures or equipment.

Prepare system verification protocols, execute tests, and compile product test results and reports.

Collaborate with external labs for standards testing and manage defect resolution with cross-functional teams.

Job description

Mandatory :

- Hands experience in Verification & Validation activities 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. Assess if any fixtures or equipment's required in advance.

- Hands experience in preparing System verification produces/protocol, execute tests and product test results & reports.

- Have Knowledge on standards like IEC60601-1-2 (EMI/EMC), ISO 80601-2-13, 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 labs/testing 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 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. Assess if any fixtures or equipment's required in advance.

- Hands experience in preparing System verification produces/protocol, execute tests and product test results & reports.

- Having experience in detailed discussion with external labs/testing 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