tendersglobal.net Job Description A Large Medical Device Company is seeking a multi-faceted, exceptionally talented, user-centered Senior Human Factors Engineer who is passionate about improving the quality of people’s lives through compelling design experiences. Job Summary and Responsibilities Our global Industrial Design and Human Factors team focuses specifically on advancing the needs of the MedTech Industry by placing our users at the center of our design process. Design solutions that span the full episode of care and balance the needs of various users: surgeons, hospital staff, patients, and caregivers. Lead human factors efforts for programs from concept through post‑market support, influencing usability activities for product lines and programs with minimal oversight. Develop a good understanding of intended use environments through time spent in the field, and a good understanding of intended user types formed through interactions with users. Work on problems of diverse scope that impact the broader program team and business, leading projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations. Network with key contacts outside own area of expertise, contribute to cross‑functional decisions, understand importance of alignment and negotiation, and represent the voice of the customer from a human factors and technical application perspective for new product development. Skills and Requirements University/Bachelor’s Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology or equivalent. 4 to 6 years of work experience in human factors/usability engineering, use case validation testing, or equivalent experience in product development and customer interactions. Demonstrated ability with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions. Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation. Expertise in planning, executing, documenting, and reporting usability testing, including moderation of studies. Knowledge of IEC 62366 standard and FDA guidance on human factors engineering. Ability to travel once a quarter. Good knowledge of ISO 14971 and IEC 14904 are a plus. Fluent in English. German and French are advantageous. Medical device product development experience or experience working in a highly regulated industry is a strong plus. Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus. Equal Employment Opportunity Statement We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status protected by applicable laws and regulations. #J-18808-Ljbffr
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