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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