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SANTA CLARA, Calif.–January 10, 2025– GlobalLogic Inc., a Hitachi Group Com...
Lead Analyst
Business Solutions
5-10 years
Ukraine - Lviv
Healthcare security, Healthcare-Medical Devices, Healthcare-Medical Workflow, IEC 62304:2006, iso 13485: 2016, Scrum
Remote, Hybrid
We are partnering with a global leader in medical devices to develop the next-generation cutting-edge tool used during hip arthroscopy for femoroacetabular impingement (FAI). Client provides surgeons with real-time visualization and measurement capabilities by superimposing virtual tools on X-ray images, enabling precise clinical decision-making. The product will help surgers to plan and to validate the procedures by analyzing 2D images from X-Rays, CT, MRI and building 3D objects.
Our goal is to enhance the product’s capabilities, improving workflow efficiency and advancing surgical outcomes. This project will involve refining requirements, designing intuitive interfaces, and integrating advanced visualization tools to meet the highest clinical standards. Join us in shaping the future of minimally invasive orthopedic surgery.
Required Qualifications
– Bachelor’s degree or higher in Human Factors Engineering, Biomedical Engineering, Psychology, or a related field.
– Proven experience as a Human Factors or Usability Engineer in the medical device industry.
– Strong working knowledge of medical device standards, particularly IEC 62366 (Usability Engineering), and its relationship to risk management (ISO 14971).
– Experience with Software as a Medical Device (SaMD).
– Experience with planning and moderating usability studies and analyzing qualitative and quantitative data.
– Excellent communication and collaboration skills to work across cross-functional teams, including engineers, designers, and clinical experts.
Preferred Qualifications
– Experience with surgical devices or applications used in a procedural setting.
– Experience with risk management tools and processes (e.g., FMEA).
We are seeking a highly motivated Human Factors Engineer to join our team in developing a next-generation surgical visualization and planning tool. This is a critical role focused on ensuring our product’s safety, effectiveness, and usability for surgeons and clinical staff in a demanding procedural environment. Your responsibilities will include
– Lead the application of the usability engineering process (per IEC 62366) throughout the software development lifecycle.
– Collaborate with the SQA and development teams to identify, analyze, and mitigate potential use-related hazards and risks.
– Develop and execute usability evaluation plans, including formative (developmental) and summative (validation) usability studies.
– Conduct tasks like heuristic evaluations, cognitive walkthroughs, and task analysis to assess the intuitiveness and safety of the user interface.
– Author and maintain the Usability Engineering File, ensuring all activities and findings are meticulously documented for regulatory submission.
– Work closely with UX/UI designers to translate findings into design requirements and provide data-driven feedback on design concepts and prototypes.
Culture of caring. At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you’ll experience an inclusive culture of acceptance and belonging, where you’ll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders.
Learning and development. We are committed to your continuous learning and development. You’ll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.
Interesting & meaningful work. GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you’ll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what’s possible and bring new solutions to market. In the process, you’ll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.
Balance and flexibility. We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way!
High-trust organization. We are a high-trust organization where integrity is key. By joining GlobalLogic, you’re placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.
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