Human Factors Engineer

ppOur client is an innovative leader in the medical technology sector, developing solutions that improve the lives of people living with chronic conditions worldwide. To strengthen its growing service offering, our client is seeking an experienced bHuman Factors Engineer Service Lead /b to drive Human Factors (HF) excellence across international pharmaceutical and combination product programs. /p pIn this strategic and customer-facing role, you will establish and expand Human Factors consulting services, advise global pharmaceutical partners on HF strategies, and lead complex usability engineering activities supporting successful product development and regulatory approvals. This is a unique opportunity to combine technical expertise, business development, and project leadership while contributing to user-centered healthcare solutions. /p h3Responsibilities /h3 ul liBuild, develop, and scale the Human Factors service offering, working closely with Business Development to identify and secure new service opportunities. /li liAct as a trusted advisor to pharmaceutical partners, providing strategic guidance on Human Factors requirements for combination products and optimizing regulatory pathways. /li liLead and coordinate international Human Factors studies, including project planning, budget management, timelines, execution, monitoring, and reporting. /li liDesign, oversee, and document formative, summative, and comparative usability studies involving diverse user populations and large participant groups. /li liManage external consultants, testing facilities, research partners, and vendors as needed. /li liLead or support Human Factors activities related to Instructions for Use (IFU), user interfaces, and overall usability engineering programs. /li liPrepare, review, and maintain usability engineering documentation required for global regulatory submissions, including Human Factors reports, study reports, and threshold analyses. /li liCollaborate with cross-functional teams to translate Human Factors insights into evidence-generation strategies, scientific publications, and product differentiation initiatives. /li liMonitor global Human Factors regulations and industry trends, contributing to the continuous development of best practices and organizational expertise. /li /ul h3Must-Haves /h3 ul liBachelor's or Master's degree in Human Factors, Ergonomics, Usability Engineering, Psychology, Product Design, or a related discipline. /li liMinimum of b7 years of experience /b in Human Factors consulting, ideally within the medical device, drug-device combination product, or related healthcare industry. /li liProven experience developing and delivering Human Factors programs, including planning, conducting, and documenting large-scale usability studies. /li liStrong project management skills with the ability to manage multiple complex projects simultaneously. /li liEntrepreneurial mindset with strong business acumen and a demonstrated ability to develop and grow customer-focused service offerings. /li liSolid understanding of global regulatory requirements and submission processes, including experience with regulatory agencies such as the bFDA, EU MDR, NMPA, and Health Canada /b. /li liExcellent stakeholder management, communication, and presentation skills with the ability to engage effectively in international and cross-cultural environments. /li liProfessional English proficiency (C1 level or higher); German is considered an advantage. /li liWillingness and ability to travel internationally up to approximately b20% /b of the time, including travel to the United States. /li /ul /p #J-18808-Ljbffr