Job#: 3054325 Job Description: Title:
Senior Human Factors EngineerTerm: 6+ months
Location: remote
Top Must-Haves:- Bachelor's Degree in Human Factors, Human Computer Interaction, Cognitive Science, Biomedical Engineering, or related discipline
- Master's or Ph.D degree preferred
- 5+ years of work experience including 3 or more years of relevant Human Factors engineering experience in the medical device industry
Role Overview
An opportunity is available for a Senior Human Factors Engineer to apply expertise to the definition, design, evaluation, and validation of next-generation medical devices and systems. This role involves joining a dynamic team of human factors engineers to contribute to the design and development of innovative medical devices. The position is for an individual with proven Human Factors leadership and skills in the regulated environment of medical device product development.
Key Responsibilities
- Author, review, and edit Human Factors engineering documentation related to assigned projects. This includes research protocols, research reports, Usability Engineering plans, Use-Related Risk Analyses, and other design control documentation.
- Support continuous improvement initiatives to strengthen Human Factors practices and documentation.
- Work cross-functionally with the core team to ensure use-related risks have been comprehensively evaluated and that appropriate risk controls are in place to ensure safe and effective use.
- Ensure the Human Factors Engineering process is in compliance with FDA recognized guidance and standards including IEC-62366, HE75, and others.
- Provide research and design inputs related to human capabilities and product interactions to inform design and contribute to the verification and validation of medical devices.
- Create and conduct formative and summative studies to support medical device design optimization and identify potential use errors.
- Analyze results from formative evaluations and make recommendations for improvements based on Human Factors guidelines and best practices.
- Participate in the development of product requirements and evaluation of risks related to product use (risk analysis).
Required Qualifications
Education: A Bachelor's Degree in Human Factors, Human Computer Interaction, Cognitive Science, Biomedical Engineering, or a related discipline is required.
Experience: A minimum of 5+ years of work experience, including 3 or more years of relevant Human Factors engineering experience in the medical device industry, is required.
Technical Skills: Candidates must have the ability to self-motivate and self-manage, possess effective verbal and written technical communication skills, and be able to plan and conduct effective meetings and presentations. The ability to collaborate effectively in multi-disciplinary teams is also necessary.
Preferred Qualifications
- A Master's or Ph.D. degree is preferred.
- Deep expertise in effectively and efficiently documenting Human Factors Engineering deliverables in the medical devices industry.
- Demonstrated experience with use-related risk analyses on medical devices.
- Background knowledge in diabetes and diabetes-care devices is strongly preferred.
- A deep understanding of FDA's Human Factors Guidance and recognized standards (HE75, IEC-62366) related to medical devices, as well as theories, principles, and data associated with human performance capabilities and limitations.
- Ability to apply Human Factors principles and methods to the design, definition, evaluation, launch, and use of medical devices.
- Experience with user-centered design methods.
- Experience with conducting formative and summative usability evaluations, including study moderation.
- Ability to direct and mentor junior staff.
Work Environment
Willingness to travel as needed (up to 25% of the time) is expected for this position.
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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