Set HF/ Usability strategy and leads human factors efforts for programs from concept through post market support, supporting and influences usability activities for product lines and programs with minimal oversight. Supervise the activities of others, and mentors on best practices in the field. Require a deep understanding of intended use environments gained through time spent in the field at a couple of locations and a good understanding of intended user types formed through interactions with users. Create formal networks involving coordination among key contacts and groups, can makes decisions that consider internal & external constraints and needs of other groups, communicates strategies; proposes potential business relationships and co-ordinates with senior leadership to deliver on program and company goals. Represent the voice of any customer from a human factors and technical application perspective for new product development beyond area of expertise. Qualifications: University/ Master’s Degree in Human Factors Engineering (HFE), or Usability Engineering. Minimum of 10 years work experience in human factors/usability engineering experience/use case validation, with at least 7 years of digital experience. Demonstrated deep understanding of alignment between human factors process and design controls. Medical Device product development 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. Demonstrated proficiency to negotiate with stakeholders and provide disposition feedback and/or suggestions for program and company goals. Expertise in planning, executing, documenting, and reporting usability testing, including moderation of studies. Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering. Good knowledge of the ISO 14971 and IEC 62304 are a plus. Fluent in English. German and French are an advantage. Ability to travel up to 20%, domestic and international is required.#LI-AM 2