Human Factors Engineer

Waltham, MA

Our client is seeking a Human Factors Engineer who is passionate about building medical device products that saves lives in the respiratory therapy arena. This early stage company is hitting its stride very nicely, with an impressive investment team and partnerships with some of the most respected names in the industry.

Responsibilities
• Apply Human Factors Engineering (HFE) techniques and principles at all phases of product/technology development.
• Develop user study criteria and detailed methodology for hardware and software user interface testing for several projects. Develop study methodology, conduct user-centered research, and evaluation for design concept models on a diverse user population and analyze data utilizing study data, anthropometric databases, and scientific publications.
• Conduct statistical and qualitative analysis of data and provide clear and concise feedback to cross-functional teams.
• Relevant experience in regulated medical device usability evaluations and documentation.
• Knowledge of regulations and best practices for medical device human factors a plus (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).
Requirements
• Masters or Bachelors degree in biosciences, engineering, respiratory therapist, nursing or equivalent discipline
• 3+ years of experience in biotechnology, pharmaceutical or medical device industries
• ICU, hospital or medical devices experience
• Good knowledge of IEC 62366
• Work experience in Human Factors Engineering/Human Factors Validation
• Proven experience throughout the product life of a combined hardware and software medical device
• Solid clinical background with understanding of human physiology, the clinical workflow and applied technologies in hospital critical care
• Ability to travel 15-30% of the time domestically and/or abroad

Preferred
• 3+ years of experience in preclinical setting or regulated medical device development (executing preclinical studies, first in human studies and IDE studies experience are a plus)
• Experience with and/or knowledge of FDA submission and approval processes

Inquiries and resumes to: Kathy Provost at kathy@agilesearchinc.com OR 978/952-6425
For more information, please visit https://www.agilesearchinc.com/

About the Author
John Compton
John has served as a Medical Device Industry Executive Recruiter, building relationships specifically in New England since 2002. He earned his BS in Mechanical Engineering from the US Military Academy at West Point, NY and is a Babson MBA. John is also a former Army Officer and US Army Ranger School Leadership Award Recipient.