Senior Human Factors Engineer

TITLE: Senior Human Factors Engineer
INDUSTRY: Medical Devices/Robotics
MODEL: Permanent, Full-Time Hire
LOCATION: SF Bay Area - Hybrid Role
JOB SUMMARY
The Senior Human Factors Engineer works closely with SW/HW engineers, clinical trainers, and product managers to inform and guide development of our surgical products, and to ensure the products are safe and effective for use. As part of product development projects, the Senior 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 analysis, usability risk analysis, conducting formative and summative evaluation studies, and ensuring usability engineering files are complete and accurate for approval by medical device regulatory agencies.
DUTIES & RESPONSIBILITIES

• Usability specifications, task analysis, usability risk analysis, and UI evaluation plans for the companies surgical products in collaboration with SW/HW engineers, clinical trainers, and product managers.
• Strategize, design, and lead formative and summative 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 Standard Operating Procedures (SOPs) for alignment with UX design guidelines
• Provide strong cross functional change agency to advance the importance and effectiveness of Human Factors Engineering principles to all product development projects.
• Reinforce a user-centered design approach across the organization.
• Other duties or MDD projects as required to meet company's objectives.

QALIFICATIONS
Required:

• Minimum BA/BS degree in Biomedical Engineering, Design, HCI, HFE or related field.
• Minimum 4-8 years of HFE and medical device development experience (based on highest degree level achieved).
• Demonstrated track record leading usability engineering activities (i.e. establishing usability requirements, creating usability risk analysis, 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 affairs.
• Experience with all phases of the product development life cycle.
• Experience working within the medical device industry under a strong QMS
• Experience/background in orthopedics and/or robotics a plus.
• Experience preparing medical device usability deliverables in accordance with IEC 62366
• Strong working knowledge of applicable standards: ISO 13485, ISO 14971, IEC 62304
• Excellent organizational skills along with strong attention to detail
• Strong communication and cross-functional collaboration skills.
• Ability to work both independently and in a collaborative team setting.
• Experience working with clinicians, laboratories or in hospital settings a plus.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System

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