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Human Factors Engineer

Company: Jobleads
Location: Fremont
Posted on: May 3, 2021

Job Description:

47201 Lakeview Blvd, Fremont, CA 94538, USA Full-time Company Description THINK Surgical, Inc., a privately held U.S.-based medical device and technology company, develops, manufactures and markets active robotics for knee replacement surgery. The TSolution OneTotal Knee Application performs automated preparation of the bone and joint surface and supports a versatile, open platform providing surgeons the flexibility of using a variety of implants. The TSolution One Total Knee Application system is comprised of TPLAN, the 3D pre-surgical planning workstation, and TCAT, the active robot that helps the surgeon execute each patient's individual preoperative plan with consistent results. These evolutionary technologies are advancing total joint replacement surgery.The TSolution Onecore technology has been used in thousands of successful total joint replacements for both hip and knee worldwide. The TSolution OneTotal Knee Application was FDA cleared in October 2019. THINK's second-generation TSolution One Total Knee Application received FDA clearance in November 2020, and is commercially available in the United States. Job Description The Human Factors Engineer works closely with SW/HW engineers, clinical trainers, and product managers to inform and guide development of THINK Surgical products, and to ensure the products are safe and effective for use. As part of product development projects, the Human Factors Engineer conducts user research, analyzes, and characterizes use-related risks, and conducts usability testing of products. This individual is responsible for supporting usability activities such as task analyses, usability risk analyses, conducting formative and summative evaluation studies, and ensuring usability engineering files are complete and accurate for approval by medical device regulatory agencies. Qualifications Required Qualifications BS degree in Human Factors Engineering, Ergonomics, HCI, or related field AND/OR 3-5 years of HFE and medical device development experience. Ability to work both independently and with a team in a collaborative setting is crucial for this position. Ability to lead usability engineering activities (i.e. establishing usability requirements; creating usability risk analyses, study protocols, and study reports) for a complex, software-controlled electro-mechanical medical device. Ability to apply user-centered design and usability engineering principles to product research, development, and design. Ability to collaborate with and across various groups and levels of management within the organization, including other engineering groups, marketing, clinical applications, and regulatory. Knowledge and experience with Microsoft Office Suite Familiar with US/EU guidance and standards related to human factors/usability, design controls and risk management and GMP. Excellent organizational skills to handle multiple projects and deliverables, along with strong attention to detail Strong communication skills for collaborating with cross-functional teams. Attendance and Punctuality are essential function of the position. Preferred Qualifications Experience working with clinicians, labs or hospital settings. Experience/background in medical devices, orthopedics, and/or robotics. Thorough knowledge of FDA Quality System Regulation, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and Medical Device Directives (MDD) requirements, IEC 62304 Medical Device Software - Software Lifecycle Processes, General Principles of Software Validation - FDA Guidance, and IEC 62366 Medical Devices - Application of Usability. Experienced with all phases of the product development life cycle including feasibility, planning, requirements, design and development, V&V, and design transfer. Understands general aspects of manufacturing and prototyping. Applied experience and thorough understanding of: FDA medical device regulations, guidance, and import/exports requirements. Medical device labeling and promotional requirements Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. COMPETENCIES Usability specifications, task analyses, usability risk analyses, and UI evaluation plans for Think Surgical products in collaboration with SW/HW engineers, clinical trainers, and product managers. Strategize, design and execute usability studies at various stages of product development from early prototypes through formative and summative evaluations. Author usability study protocols and reports, moderate studies, and analyze study data. Manage and drive company SOP's /policies/ procedure for alignment with UX design guidelines Reinforce a user-centered design approach across the organization. Other duties or MDD projects as required to meet company's objectives. PHYSICAL DEMANDS & WORK ENVIRONMENT Must be able to remain in a stationary position and operate office equipment for a prolonged period of time. Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs. Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders. Occasionally work around moving mechanical parts. Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours. Must be able to travel as business necessitates (up to 20 % Travel) Additional Information THINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow's leading orthopedic solutions today, we would love to hear from you. THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation. 47201 Lakeview Blvd, Fremont, CA 94538, USA

Keywords: Jobleads, Fremont , Human Factors Engineer, Other , Fremont, California

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