Senior Human Factors Consultant – Remote
Kymanox is seeking a Senior Human Factors (HF) Consultant/Engineer to join the Human Factors Regulatory and Strategy Business Unit. The HF Engineer will work alongside experts in Human Factors and Usability Engineering and support Kymanox projects which provide professional services for its Biomedical, Pharmaceutical and Medical Device Clients.
Bachelor’s degree in a science related field such as Biomedical Engineering, Cognitive Engineering or Human Factors. Master’s preferred, but not required.
A minimum of 5-7 years’ experience working as a Human Factors Engineer at the FDA or in the Medical Device or Pharmaceutical industries
- Drafting responses to FDA correspondence and communications
Drug/Device Combination product/Medical Device and HE Execution experience
- Drafting HF documentation in support of submission to FDA/notified bodies.
Familiarity with FDA Guidance and ISO standards on Human Factors including, but not limited to:
– FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices, February 2016
– ANSI/AAMI/IEC 62366 1:2015. Medical devices – Part 1: Application of usability engineering to medical devices. Usability engineering process.
– ISO 14971:2007. Medical devices — Application of risk management to medical devices
- Knowledge and experience with 21 CFR 820.30 Design Controls as well as CFR part 4 requirements for Drug/Device combination products
- Experience in Usability Risk Management including using use risk analyses tools such as hazard analyses, Use FMEA, Task Analyses, and other risk assessments
- Strong Technical Writing experience and HF/UFE Report writing in accordance with FDA HF Guidance
- Experience writing protocols and reports for Preliminary Evaluations (Formative Studies) as well as User Interface Design Validation Studies, and experience with conducting and/or moderating HF Studies
- HF Project Management experience preferred
The Human Factors Engineer will support clients in the above aforementioned HF practices and aid in execution of client HF programs. The Senior Human Factors Engineer will have the opportunity to develop his or her skillset with HF strategy working with seasoned leadership in HF, both from industry and from the FDA.
Desired Aptitude and Skill Set:
- Extremely detail oriented
- Ability to work effectively with remote team members
- Highly organized
- Self-directing, self-pacing
- Excellent written and oral English communication skills
- Understanding of own limitations
- Ability to solicit and utilize subject matter expert input
- Fast learner
- Ability to motivate self and team members
- High energy level
- Excellent problem-solving skills
- Seasoned soft skills (i.e., high EQ)
- Team player
- Thrive in a fast-paced, growing, and dynamic work environment
- Technology savvy
Up to 5-10% remote travel may be required from time to time.
Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.