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Senior Human Factors Engineer
1 month ago
At THINK Surgical, Inc., we are seeking a highly skilled Senior Human Factors Engineer to join our medical device development team. As a key member of our team, you will play a critical role in ensuring that our medical devices are safe, effective, and user-friendly for healthcare professionals and patients.
Key Responsibilities:- Collaborate with product owners and development teams to ensure and enhance product usability and safety.
- Apply principles of human factors engineering and usability to optimize device design, reduce use errors, and enhance overall user experience.
- Lead cross-functional teams to conduct formative and summative studies for the entire product portfolio.
- Analyze study results and provide actionable recommendations for device design improvements.
- Participate in the complaint process and perform root cause analysis of observed use errors.
- Create human factors usability documents, task lists, use error risk assessments, test protocols, and reports for regulatory submissions.
- Bachelor's degree in Human Factors, Usability Engineering, Biomedical Engineering, Industrial Design, or a related discipline with relevant experience.
- 5+ years of Human Factors experience in a regulated industry (FAA, FDA, DOD, etc.).
- Excellent verbal, written, and communication skills, including the ability to present complex ideas to technical and executive teams.
- Ability to collaborate with and across various groups and levels of management within the organization.
- Excellent organizational skills along with strong attention to detail.
- Working understanding of the full product life cycle from inception to post-market surveillance.
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
- Master's degree in Human Factors, Usability Engineering, Biomedical Engineering, or Industrial Design.
- Experience/background in orthopedics and/or robotics.
- Desire to mentor, teach, and evangelize design thinking methodologies.
- Experience with UX and UI design.
- Working knowledge of Jira and Confluence.
- Drive results.
- Optimize work processes.
- High-quality work and documentation.
- Time Management.
- Effective communication and collaboration.
- Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
- Physical activities include, but are 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 are 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%).