Project Lead - Verification & Validation

☞ Dräger

看过: 107

更新日: 23-04-2024

位置: Vasai Maharashtra

类别: 其他

行业:

工作类型: Full-time

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工作内容

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

- Strong in understand the scope of work, estimate efforts required & resources, Prepare strong project plan and execute on time.

- Define resource skill sets required, build team and execute on time.

- Good in Analyze requirements, assess early are these requirements are testable or not. Assess if any fixtures or equipment’s required in advance.

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

- Hands experience in preparing System verification plan, 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.

- Have working experience in Complaince scheme (CE) certification test (MDD or MDR), submit all required compliance certificate/reports and address concerns raised by regulatory.

- 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.

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

- Report out to leadership about time line and quality of product periodically.

- Good knowledge on Agile methodologies to drive SW verification execution

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

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最后期限: 07-06-2024

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