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
Skill(s) required
Circuit DesignEmbedded SystemsPCB DesignRobotic Process Automation (RPA)Robotics
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.
Added requirements
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
Perks
Certificate Letter of recommendation Informal dress code
Comofi Medtech Private Limited is a med-tech startup developing assistive surgical robots. We are building a next-gen healthcare robotics company. We are a team of experienced professionals working at the junction of mechanical engineering, electrical engineering, electronics engineering, and computer science. Our research and development efforts are based out of our office in Yelahanka, Bangalore.