Key Responsibilities

1. Perform the Functional and Performance testing for the Medical electrical equipment products

2. Support Design engineers in Test fixture creation, building up & tearing down Test equipment.

3. Support Lab logistics and Support Calibration activities.

4. Experience in IEC basic safety, EMI-EMC standards.

5. Basic understanding of and adherence to FDA,MDD/MDR, ISO and IEC design control procedures, regulations and standards.

6. Relevant technical testing/reliability experience in electromechanical, electrical testing of Medical Devices

7. System V&V; Engineer with experience in Visualization system, shaver system and RF system design verification testing most preferred.

8. Perform Installation/Operational/Performance Qualification Protocols

9. Responsible for reviewing and approve the prospective, concurrent, retrospective, and revalidations.

10. Responsible to Review and sign the TOT (Technology over transfer) documents from R&D; stage to Production stage

11.



Point of Contact for all Internal and External Audits

12. Review the NCP, CAPA and Change control of the processes at HML plant

13. Responsible to review and approve the Pilot batches for the recent products or line-extension products at HML plant

14. Responsible to ensure the R&D; team follow the latest ISO/ASTM/IS standards related to the QMS/Product design/testing. It includes (but not limited to) ISO 13485:2016, Regulation (EU) 2017/745, MDSAP, BGMP, 21 CFR part 11, 21 CFR part 820, 21 CFR part 803, 21 CFR part 806, Indian MDR, ISO 11135, ISO 11737-1, ISO 11737-2 & ISO 11737-3.

Qualification

- Post-graduate /Graduate in Engineering/Science

Work Experience

- 5-10 years of experience in Quality Engineering/NPD/V&V; (Preferred for Candidate worked in Medical devices or Pharmaceutical industry)

📌 Assistant Manager (Gujarat)
🏢 Healthium Medtech
📍 Gujarat