Product Compliance (Medical Devices) Jobs in Bangalore - Comofi Medtech Private Limited
Job Description
1. Preparing documents (SoPs, testing records, reports, etc.) according to IEC 60601-1, 60601-1-2, IEC 62366, and guidelines
2. Assisting in 60601-1 dossiers and reports file preparations
3. Understanding and interpreting IEC60601-1 (medical product safety) and related standards
4. Carrying out design analysis to support the development of products within the boundaries of safety standards and assisting in the identification, analysis, and control of conditions impeding product safety
5. Conducting and coordinating safety testing including EMI/EMC and wireless compliance, on existing and new products to ensure safety compliance according to IEC 60601-1-2, and evaluate test results
6. Determining compliance by establishing compliance test standards, conducting and witnessing tests, performing diagnostic procedures, measuring performance, analyzing and evaluating findings, and performing forensic analysis of failure
7. Interacting with external manufacturing locations during agency audits, as needed
Only those candidates can apply who:
1. are available for full time (in-office) internship
2. can start the internship between 28th Dec'20 and 1st Feb'21
3. are available for duration of 6 months
4. have relevant skills and interests
* Women wanting to start/restart their career can also apply.
1. Candidate can either be pursuing biomedical engineering/electrical engineering graduate or from electronics and electrical stream
2. He/She must have a sound understanding of regulatory requirements in medical devices like IEC 60601-1, 1-2, electrical compliance testing, and biological evaluation of medical devices, and CE certification process
3. Candidate should have excellent writing skills and a strong interest in product compliance and testing
Certificate: Will be provided at the end of the Internship