Essential, part of PA Consulting, is a multidisciplinary design, development and innovation studio that became part of PA Consulting’s global organization in 2018. Our clients are agents of change at the world’s leading brands in consumer, tech, healthcare and industrial sectors. Founded in 2000, we are based near South Station, directly in the heart of Boston’s Innovation Economy. 

Your day to day

As part of our continued growth, we are expanding the Human Factors Engineering team in our Boston studio. The broader Human Factors Engineering group is based in both Boston, MA and Cambridge, UK, and is located within PA’s Design & Engineering umbrella, helping support PA’s product development offering, which provides end to end innovation, proof of concept, prototyping and later stage development/product lifecycle services. Our Human Factors team works alongside a wide range of medical device and pharmaceutical companies; be it global leaders or startups. 

We are a human-centered group that partners with our clients to provide expert HF consulting services, whether it’s delivering an entire usability engineering program alongside device development teams, guiding clients on HF regulatory strategy, providing HF advisory support to our in-house teams, or conducting generative, formative, validation, and comparison studies. We often support product development efforts where we collaborate with designers, engineers, and scientists to ensure products meet users’ needs, from concept generation through launch.  

You will be joining a highly skilled and friendly team that promotes autonomy, trust, flexibility, and support for your career growth and development, in line with your goals. The majority of the role can be completed from home, but travel to the office, client, or research site will be required for certain projects, such as physical prototype development with the engineering and industrial design team, study conduct, and occasional team events.   

What you bring

• At least 3-5 years of consulting and/or industry experience (Senior HFE) or 6+ years of experience (Principal HFE) 

• Bachelor’s, MS, or PhD in Human Factors Engineering, HCI, Behavior Sciences, Experimental Psychology, Cognitive Science, Computer Science, Industrial Design, Systems Engineering, Biomedical Engineering or a related field.   

• Demonstrated knowledge and application of relevant HF standards and guidance for medical devices, combination products, and health IT (e.g., IEC 62366 and FDA guidance) 

• Experience applying usability engineering processes to medical device development, including: 

• Usability Engineering file development (e.g., use specifications, expert reviews, user interface specifications, known use problem analysis, HFE summary report) 

• Understanding of use-related risk activities, such as task analyses and Use-FMEA.  

• Formative and summative (validation) study planning, moderating, observation, analysis, and reporting.  

• Project management and/or project leadership experience. 

• A desire for a hands-on human factors position involving study conduct and a willingness to travel domestically and internationally when needed (NOTE: travel varies based on project needs and in-line with COVID policies; typical travel for this role is approximately 20% of the year.) 

• The ability to present complex data in a compelling and concise manner verbally and visually. 

• We welcome individuals with a background in other (non-healthcare) sectors if they demonstrate a strong willingness and ability to learn and adapt to new regulations, standards, and technical domain knowledge.  

Nice-to-haves 

• An understanding of the medical device development process overall, including design controls and verification and validation. 

• Familiarity with ISO 14971 and risk management processes.  

PA Consulting is an equal opportunity employer. We are committed to building an inclusive and supportive culture where diversity thrives, and all of our people can excel. You do not need to match every expectation above to apply for this position. We believe bringing together diverse perspectives yields innovative ideas, supporting our objectives to create exceptional value for our clients and exceptional experiences for our engineers. 

We recruit, promote, and reward our people based on their contribution, without regard to gender, race, disability, religion, nationality, ethnicity, sexual orientation, age, or marital status.