Staff Human Factors Engineer (Andover, MA)

Smith+Nephew•Andover, MA

1d•Hybrid

About The Position

Staff Human Factors Engineer (Andover, MA) Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Smith + Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients. We do this by taking a pioneering approach to the design of our advanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems. We have leadership positions in: Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds Sports Medicine - minimally invasive surgery of the joint Trauma & Extremities - products that help repair broken bones We have around 15,000 employees around the world. Annual sales in 2018 were more than $4.7 billion. We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NY) What will you be doing? As part of the Smith + Nephew Human Factors team the Staff Human Factors Engineer will lead usability and design efforts across a number of Smith & Nephew's life changing device programs. You will demonstrate and champion user-centered design principals, employ design thinking activities, identify unmet needs and generate design requirements while ensuring human factors and usability regulatory requirements are met. In addition to providing design and usability guidance, this position will lead ethnographic research activities that will craft and define business strategies across a variety of medical device products and services. As a Usability authority, you will contribute to the establishment and adoption of organizational human factors operating procedures and processes. You will lead research across multiple programs to understand users (clinicians and lay users), use environments, user characteristics, behaviors and constraints. You will support the delivery of projects by developing and leading strategies, informing design through user research, reviewing HF literature, iteratively testing concepts, leading external partners and compiling reports for submission to regulatory authorities. You will provide ongoing assessment where changes to an existing product user interface are proposed, identifying any additional work required. You will develop and maintain Usability processes and procedures in order to streamline product development and maintain regulatory compliance. You will develop and maintain an understanding of the latest information regarding Usability and Human Factors testing for medical devices. You will maintain a network of external contacts who can be referred to for advice when appropriate. You will ensure all activities are performed in accordance with relevant national and international standards. You will ensure all activities are performed and maintained in the QMS in accordance with relevant national and international standards. You will place special emphasis on IEC62366 – 1, the FDA’s guidance Applying Human Factors and Usability Engineering to Medical Devices, and the NMPA Guidelines for the review of medical device usability engineering registration. Travel Up to 25%

Requirements

Bachelor´s degree in relevant area (Human Factors, Industrial Design, Cognitive Psychology, Engineering)
8+ years’ experience in product development with the application of Human Factors Engineering to product/system design
Project and third party management experience (budget >$100k)
Significant working knowledge of Usability/Human Factors Engineering in a medical device environment
Experience moderating usability studies
Knowledge and understanding of Human Factors/Usability standards
Experience of working on medical devices, capital equipment, software GUI’s
Strong organizational, prioritization and communication skills
Proficiency using generative Ai tools for varied applications
Software proficiency: Microsoft Office Suite: Teams, OneDrive, Copilot Word, PowerPoint, Excel, Outlook

Nice To Haves

Human Factors/Ergonomics Master´s Degree, Ph.D. Human Factors/Ergonomics qualifications a plus
Preferred: experience with usability engineering for complex systems (e.g., computer-assisted surgery, robotic surgery, visualization)
Preferred experience with usability engineering for surgical devices
Adobe Creative Suite, Jama, Jira, Figma

Responsibilities

Lead usability and design efforts across a number of Smith & Nephew's life changing device programs.
Demonstrate and champion user-centered design principals, employ design thinking activities, identify unmet needs and generate design requirements while ensuring human factors and usability regulatory requirements are met.
Lead ethnographic research activities that will craft and define business strategies across a variety of medical device products and services.
Contribute to the establishment and adoption of organizational human factors operating procedures and processes.
Lead research across multiple programs to understand users (clinicians and lay users), use environments, user characteristics, behaviors and constraints.
Support the delivery of projects by developing and leading strategies, informing design through user research, reviewing HF literature, iteratively testing concepts, leading external partners and compiling reports for submission to regulatory authorities.
Provide ongoing assessment where changes to an existing product user interface are proposed, identifying any additional work required.
Develop and maintain Usability processes and procedures in order to streamline product development and maintain regulatory compliance.
Develop and maintain an understanding of the latest information regarding Usability and Human Factors testing for medical devices.
Maintain a network of external contacts who can be referred to for advice when appropriate.
Ensure all activities are performed in accordance with relevant national and international standards.
Ensure all activities are performed and maintained in the QMS in accordance with relevant national and international standards.
Place special emphasis on IEC62366 – 1, the FDA’s guidance Applying Human Factors and Usability Engineering to Medical Devices, and the NMPA Guidelines for the review of medical device usability engineering registration.