Job Requirements
• Experience in Gathering requirements, defining high level product
• Prepare usability specification and the requirements for usability test.
• Experience in conducting formative and summative usability studies.
• Coordinating project planning and execution with team members and team leads.
• Should have worked on 510K and MDR regulation on Clinical studies and Usability.
• Conduct Market and User Research to define the enhancement required in product lifecycle.
• Experience in risk analysis, change control, ISO audits, regulatory technical documentation preparation, systems review, V&V activities.
• Maintain key customer relationships and plan customer acceptance and usability testing
• Good understanding of healthcare domain (regulations and standards IEC62304, ISO13485, IEC62366, IEC 60601)
• Experience in using tools like DOORS, Oracle Agile, RQM
Work Experience
• Bachelor's degree in biomedical / Electronics Engineering with 10 to 15 years of work experience in medical device Usability engineering and Product management.
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