Lead Usability Engineer, Medical Devices & Equity

Anteris Technologies; Brooklyn Park (MN); On-site; USD 131,000 - 151,000; Full time

Benefits offered by this job

Health insurance

401k + Company Match

Bonus Plan Eligibility

Employee Equity Program

Paid Holidays & Vacation

Job summary

Anteris Technologies is seeking a Senior Usability/Human Factors Engineer to lead usability efforts for the DurAVR TAVR valve and delivery system. You will collaborate with R&D, regulatory, and clinical teams to ensure safe, effective, and user-friendly devices throughout product development.

Responsibilities include prototyping, user research, usability testing, and regulatory documentation in line with ISO 62366, ISO 14971, and FDA guidance.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Human Factors Engineering, or related field required.
• Minimum of 5 years of usability engineering experience for medical devices.
• Experience with interventional technologies and TAVR is preferred.
• Strong knowledge of human factors engineering principles and regulatory requirements.
• Experience with user-centered design, usability testing, and risk management.

Responsibilities

• Provide usability engineering leadership across the product development lifecycle.
• Develop and implement usability engineering processes, strategies, and plans.
• Integrate human factors into product requirements and design across functions.
• Lead prototyping, user research, and usability testing activities.
• Ensure ISO and FDA Human Factors guidelines compliance; prepare usability documentation.

Skills

Usability engineering

Human factors

Regulatory compliance

Cross-functional collaboration

Project leadership

Education

Bachelor’s degree in Biomedical/Mechanical/Human Factors

Tools

Usability software tools

Job description

Anteris Technologies is seeking a Senior Usability/Human Factors Engineer to lead usability efforts for the DurAVR TAVR valve and delivery system. You will collaborate with R&D, regulatory, and clinical teams to ensure safe, effective, and user-friendly devices throughout product development.

Responsibilities include prototyping, user research, usability testing, and regulatory documentation in line with ISO 62366, ISO 14971, and FDA guidance.