Senior Human Factors Engineer (Andover, MA)

Smith+Nephew•Andover, MA

1d•Hybrid

About The Position

Senior 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 a Senior Human Factors Engineer on the Smith+Nephew Human Factors+Design team, you will lead user research and usability engineering activities for innovative devices used by clinicians and patients worldwide. This role combines deep regulatory expertise with hands-on‑ design influence, shaping product strategy from early discovery through regulatory submission and launch. As the owner of HF strategy for assigned programs, you will support the delivery of projects by informing design through user research, reviewing HF literature, iteratively testing concepts, leading external partners and compiling reports for submission to regulatory authorities. You will also make independent recommendations to cross-functional leadership and serve as the HF subject matter expert during regulatory interactions. With a primary focus in Sports Medicine and ENT programs, you will lead research across multiple programs to understand users (clinicians and lay users), use environments, user characteristics, behaviors and constraints. You will lead formative and summative usability studies, ethnographic research (e.g., OR observations, in-home‑ use evaluations), task analyses, contextual inquiries, and iterative concept evaluations to inform both product design and business strategy. 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. For existing products where changes to the user interface are proposed you will provide an ongoing assessment, identifying any additional work required. You will develop and maintain an understanding of the latest information regarding Usability and Human Factors testing for medical devices. 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. You will maintain a network of external contacts who can be referred to for advice when appropriate. Travel Up (international and domestic) up to 25%

Requirements

Bachelor's Degree in relevant area (Human Factors, Industrial Design, Cognitive Psychology, Engineering)
5-8 years’ experience in product development with the application of Human Factors Engineering to product/system design, preferred in a regulated industry
Project and third party management experience (budget >$100k)
Significant working knowledge of Usability/Human Factors Engineering in a medical device environment
Experience designing, moderating, and reporting on usability studies
Knowledge and understanding of Human Factors/Usability standards for medical devices and human-centered design principles
Experience of working on medical devices, capital equipment, software GUI’s
Experience working closely with design teams
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 MS, PhD, or certification
Adobe Creative Suite, Jama, Jira, Figma

Responsibilities

Lead user research and usability engineering activities for innovative devices used by clinicians and patients worldwide.
Own HF strategy for assigned programs, you will support the delivery of projects by informing design through user research, reviewing HF literature, iteratively testing concepts, leading external partners and compiling reports for submission to regulatory authorities.
Make independent recommendations to cross-functional leadership and serve as the HF subject matter expert during regulatory interactions.
Lead research across multiple programs to understand users (clinicians and lay users), use environments, user characteristics, behaviors and constraints.
Lead formative and summative usability studies, ethnographic research (e.g., OR observations, in-home‑ use evaluations), task analyses, contextual inquiries, and iterative concept evaluations to inform both product design and business strategy.
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.
Provide an ongoing assessment, identifying any additional work required for existing products where changes to the user interface are proposed.
Develop and maintain an understanding of the latest information regarding Usability and Human Factors testing for medical devices.
Ensure all activities are performed and maintained in the QMS in accordance with relevant national and international standards.
Maintain a network of external contacts who can be referred to for advice when appropriate.