Usability Engineer - Medical Devices
Location
Pune | India
Job description
Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT.
Tata Elxsi's Medical Device and Healthcare practice is ISO 13485 certified.
Job role: Usability Engineer - Medical Devices
Experience Level: 3-10 Years
Overview:
Join our regulatory services team as a Usability Engineer specializing in the medical device industry. We are seeking a candidate with 3-10 years of experience in usability engineering, who can ensure compliance with regulatory requirements while enhancing the usability and safety of medical devices.
Responsibilities:
- Conduct thorough usability engineering activities while adhering to regulatory guidelines.
- Collaborate closely with regulatory affairs teams to integrate usability requirements into submissions for regulatory approval.
- Develop and execute usability test plans, protocols, and reports aligned with regulatory expectations.
- Analyze and interpret usability test data to provide insights for regulatory submissions and product improvement.
- Work collaboratively with cross-functional teams to align usability engineering with regulatory and quality management processes.
- Ensure compliance with relevant standards, including ISO 62366 and FDA Human Factors Guidance, throughout the product development lifecycle.
- Participate actively in risk management activities related to human factors and usability.
- Provide expert guidance on labeling and instructional materials to meet regulatory expectations.
Qualifications:
- Bachelor's or master's degree in Engineering or related field.
- 3-10 years of practical experience in usability engineering within the medical device industry, with a focus on regulatory compliance.
- In-depth knowledge of regulatory requirements and standards pertaining to medical device usability.
- Proficient in using tools for usability testing, with an understanding of regulatory expectations for testing methodologies.
- Excellent communication skills, with the ability to articulate findings and recommendations for both usability and regulatory purposes.
- Familiarity with medical device development processes, design control, and regulatory submissions.
- Detail-oriented, ensuring the highest standards of user safety and satisfaction while meeting regulatory expectations.
- Ability to work effectively in a collaborative, team-oriented environment.
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