Human Factors Engineer

Concord USA•Open to multiple locations in the US, MN

1d•Remote

About The Position

We are seeking a Human Factors Engineer with knowledge of medical device usability. In this role, you will join our client's global customer experience and solution design team to redefine user interface and product design and help transform the healthcare industry. You will work with an international group of designers dedicated to bringing the voice of the customer to the core of product decisions — designing and enabling a seamless, patient-centric experience across a portfolio of medical devices and services.

Requirements

Must be authorized to work legally in the US without sponsorship, now or in the future.
5+ years of experience in applied Human Factors Engineering and Design Control Management.
Master's degree in Science, Industrial Engineering, Human Factors Engineering, or a related technical field.
Experience with the Usability Engineering process for medical devices.
Proven ability to plan, execute, and document usability studies in a medical context.
Solid knowledge of ISO 14971, IEC 62304, and IEC 62366.
Experience in collecting and analyzing physiological and behavioral data.
Excellent communication and presentation skills.
Fluency in English required.

Nice To Haves

Experience creating, facilitating, and analyzing workshops with end users and engineers is a strong plus.
Additional languages are a plus.
Knowledge or background in UX or UI design is a plus.

Responsibilities

Serve as the voice of patients and end users in all product-related discussions.
Analyze user profiles, tasks, hazard-related use scenarios, usability risks, requirements, and HF-related V&V.
Create medical device usability deliverables in accordance with IEC 62304, and FDA guidance on Human Factors Engineering.
Plan and execute formative and summative usability studies; coordinate external suppliers as needed.
Prepare, maintain, and review Usability Engineering Files for multiple products.
Advocate for safety, efficacy, accessibility, quality, and usability for end users.
Provide guidance and mentorship on Human Factors Engineering practices to other design team members throughout the product design and development process.