Human Factors Engineer

Posted 2 months ago

Contribute to advancing robotic-assisted surgery while working for a company that respects, values, and appreciates all team members!

Why you will love working at Virtual Incision:

Strong mission to expand access to robotic-assisted surgery, one of the most exciting fields in healthcare today.
Company-wide dedication to clinical excellence, innovation, and teamwork
Friendly, open, and fun culture where people genuinely like each other
Opportunity to take ownership on exciting projects from day one.
Career development through fast pace and an all-hands-on-deck culture
Mentorship from some of the top industry experts
Flexible working hours, including paid vacation and holidays.
Healthcare programs including medical, dental, vision, disability, and life insurance.
401(k) retirement plan

Job summary:

As a Human Factor Engineer, you will work collaboratively across the entire organization to help understand user needs and use risks for current and future designs of the MIRA Surgical System to reduce the potential for patient harm. Human Factors Engineering is an integrated part of our design and development process, this role will directly contribute to design assessments and conduct usability testing in compliance with medical device Human Factors standards and FDA regulations, as well as ideating with the team on solutions to improve the user experience and reduce use risk.

Responsibilities:

Contribute during all phases of the product development cycle with particular emphasis on Human Factors Engineering and Usability Assessment
Act as an interface between the product development team and other related disciplines (i.e., regulatory, clinical, marketing, quality, manufacturing, and other functions) regarding potential use error issues as they may relate to user/patient safety.
Perform analytical use risk analysis to predict and/or assess use error risk potential and identify potential design mitigations.
Execute and support formative usability studies during concept development and summative usability studies for human factors validation.
Develop clear testing protocols, set up testing environments, moderate usability sessions, analyze testing results, identify design improvement opportunities, and create summary reports that adhere to industry standards.
Collaborate on user needs/requirements gathering activities including ethnographic research, use case analysis, and/or task analysis.
Follow standard operating procedures related to Human Factors Engineering and other applicable regulations in the execution of all activities.
Contribute to process improvement initiatives.
Provide oversight and support for human factors activities executed by third party partners/consultants.

Qualifications:

Minimum of bachelor’s degree in Design, Engineering, or Bio-Medical. Engineering background with advanced degree in Human Factors or another related field preferred.
A minimum of 3 years of experience performing the role of Human Factors Engineer working with medical devices desired.
Understanding of current medical device Human Factors standards (ISO 14971:2019, IEC 62366-1:2015/Amd1:2020) and FDA requirements.
Statistical data analysis expertise desired.
Ability to manage schedules and budgets for Human Factors activities on projects.
Strong written and oral communication skills including effective communication with a variety of stakeholders including surgeons and other healthcare professionals.
Ability to work individually and as a member of an interdisciplinary team, managing simultaneous responsibilities.
Be open to broadening their understanding of regulatory requirements related to Human Factors
Strong sense of empathy for clinicians and patients