Senior Human Factors Specialist

Our Team

Our small and close-knit team is made up of individuals who have been working human factors for longer than we care to admit. We are fierce in most everything we do as our goal is to optimize not only our clients’ experience but to put them in the best position possible when it is time for FDA review. We do not view human factors as just another checklist; we view human factors as a critical component of not only a successful submission but a successful product.

Overview

The Senior Human Factors Specialist is responsible for providing high level expertise and consultation on human factors activities. More importantly, our technical directors are primary contributors as it pertains to study protocol development, study moderation, and reporting. Our direct contribution to studies, coupled with our senior-level program management, is one of our key differentiators in the marketplace. Our Senior Human Factors Specialist thrive in our fast-paced environment working with multiple clients and on multiple programs at any given time.

The Technical Director duties and responsibilities include but are not limited to:

1. Manage multiple programs and projects at various stages of the human factors timelines (e.g., early in the client’s product development or late-stage).
2. Plan, conduct, and report on human factors activities in support of customer programs. You will be expected to moderate your own studies or support by moderating other studies as needed.
3. Activities may include but are not limited to:
   1. Authoring protocols and reports.
   2. Study moderation (yes, we moderate our own studies and help each other when we need to).
   3. Authoring use-related risk documentation.
   4. Helping clients with FDA requests / attending FDA meetings (usually virtually).
   5. Plan HF strategies that are not overly burdensome and are pragmatic / make sense.
   6. Support finance by managing our budgets, 3rd party contractors, so we can know when and who to invoice.
   7. And in general, help our clients solve hard problems and bring cool new stuff to market! Not getting it stuck in a bunch of red tape!
4. Maintain expertise in human factors knowledge and methods and human factors regulatory requirements ensuring the knowledge is current and in keeping with the latest industry trends.
5. Manage contractors or other vendors, including 3rd party recruiters and facilities, as appropriate.
6. Conduct work activities in compliance with negotiated timelines and budgets.
7. Identify and communicate to Human Factors MD new opportunities to support clients or new work prospects in support of Human Factors MDs business development objectives.
8. Provide support and guidance to other staff members as appropriate.
9. Conduct work activities in accordance with Human Factors MD Quality Management System
10. Carry out any other tasks as assigned by the Managing Director.

Preferred Qualifications

1. Graduate degree in Human Factors or a related discipline.
2. A deep understanding of the healthcare industry and ecosystem including device usage and roles and responsibilities of participants.
3. Minimum of 7 years of experience planning, preparing, and conducting human factors exploratory, formative, and summative (validation) studies for medical devices and combination products.
4. Experience creating use-related risk documentation for medical devices and combination products, with specific experience creating Use-Related Risk Analyses following the FDA guidance (i.e., beyond the FMEA).
5. Working knowledge of human factors standards and guidelines for medical devices and combination products (e.g., FDA/CDER human factors guidance, FDA/CDRH human factors guidance, IEC 62366, HE 75, guidance for OTC products).
6. A strong skillset creating human factors testing protocols ranging from formative study protocols using various experimental methods to more rigid human factors validation test protocols.
7. Proven project management skills and ability to prioritize and balance multiple projects as all our Technical Directors are expected to effectively lead multiple programs concurrently.
8. Superior moderation skills and comfort with direct study moderation, especially studies sensitive in nature or working with lay people in such a way that collects data but also makes people feel comfortable.
9. Ability to work independently with minimal supervision in a distributed company.
10. Effective team-player with proven leadership ability.
11. Demonstrated customer-management skills with the desire to
12. Excellent written and verbal communication skills; strong presentation skills and technical writing ability.
13. Strong analytical and problem-solving abilities; detail-oriented, self-driven, fast-learner.
14. Ability to travel to study sites throughout North America at least five days per month.

Position is full-time, Monday to Friday, 8am - 5pm.  Candidates currently living within a commutable distance of Charlotte, NC are encouraged to apply. 

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.