Lead Usability Engineer

Job summary

The Lead Usability Engineer will play a crucial role in ensuring that hearing devices comply with high usability and regulatory standards within the Regulatory Operations department. This position involves collaboration with a quality-driven team focused on delivering user-centered products for individuals with hearing loss.

Qualifications

• Relevant academic background in engineering or a related field.
• Direct experience in usability engineering within a medical device environment.
• Knowledge of IEC 62366 and/or FDA Human Factors Engineering guidance.
• Experience with complex and technologically advanced medical devices.
• Proficient in English, both written and spoken.

Responsibilities

• Drive regulatory product compliance in usability engineering for new product development.
• Establish, maintain, and improve usability engineering processes and documentation throughout the product lifecycle.
• Act as the lead usability specialist and subject-matter expert.
• Support regulatory submissions, audits, and authority responses related to usability and human factors engineering.

Skills

• Strong communication skills to engage and influence stakeholders with varying levels of regulatory and usability knowledge.
• Interest in promoting improvement initiatives and sharing knowledge with peers.

Education

• A degree in engineering or a related field is required.

Tools

• Familiarity with usability engineering tools and methodologies relevant to medical devices.