Product Cybersecurity Manager (Contract)

JOB SUMMARY

The Senior Human Factors Engineer will join our medical device development team. In this role, you will be responsible for ensuring that our medical devices are safe, effective, and user-friendly for healthcare professionals and patients. You will apply principles of human factors engineering and usability to optimize device design, reduce use errors, and enhance overall user experience. This is a contract position is based in Fremont, CA.

DUTIES & RESPONSIBILITIES

• Collaborate with product owners and development teams to ensure and enhance product usability and safety.
• Reinforce a user-centered design approach across the organization.
• Apply knowledge of FDA, ISO, AAMI and other relevant regulations and standards to the full product life cycle.
• Lead cross-functional teams to conduct formative and summative studies for the entire product portfolio (web application to surgical robots).
• 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 list, use error risk assessment, test protocols and reports for regulatory submissions.
• Track evolving regulations and industry standards relevant to medical devices to ensure quality processes are up to date.

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS

Required:

• Bachelor's degree in in Human Factors, Usability Engineering, Biomedical Engineering, Industrial Design or in 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 including other engineering groups, marketing, clinical applications, and regulatory affairs.
• 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.

Preferred:

• 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.

COMPETENCIES

• Drive results
• Optimize work processes
• High quality work and documentation
• Time Management
• Effective communication and collaboration

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 %).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.

THINK Surgical, Inc. ("THINK") is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with their employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee's eligibility to work in the United States. Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.