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Location: Bengaluru
Company: UST
Minimum Qualifications
- B.E. from reputed university in Computer Science; Electronics; Biomedical; Instrumentation
Engineering - 4+ years in product development of complex electro-mechanical devices controlled by SW; with 3+ years in testing roles
- Knowledge of medical device quality and regulatory standards (ISO 13485; ISO 14791; IEC
60601; IEC 62304; etc.) - Strong written and verbal communication skills; with attention to detail and thoroughness
- Able to work in direct; cross-functional and cross-cultural teams; with strong influencing skills
- Able to participate in late evening and/or early morning calls
- Self-starter; strong work ethic and initiative in accomplishing objectives; and delivering in ambiguous environments
Job Responsibilities
- Create and review test protocols for verifying and validating software and system requirements
- Establish system validation plan; Develop test method protocols; Execute tests / produce test result documentation / review test results for system testing and pre-clinical evaluation as per the applicable regulatory standards.
- Participate/Lead risk assessments and develop mitigation plans to ensure safe operation of the product
- Participate in strategic discussions and own the technology development for the future
generation of the product
