Principal Human Factors Engineers

Kymanox

6d•Hybrid

About The Position

Kymanox is seeking a Principal Human Factors Engineer to lead and execute Human Factors Engineering (HFE) and Usability Engineering (UE) programs that support the development of safe, effective, and user-centered medical devices and combination products. This role is focused on providing strategic human factors leadership, regulatory guidance, user interface development support, and end-to-end execution of HF/UE activities across the product lifecycle. You will collaborate with cross-functional client teams, regulatory and engineering stakeholders, research participants, and fellow consultants to deliver high-quality human factors solutions that improve patient and user outcomes. We are looking for a seasoned leader who is passionate about medical product development, possesses deep expertise in human factors and usability engineering, and enjoys mentoring others, solving complex challenges, and identifying opportunities to advance both client success and Kymanox's service offerings.

Requirements

15+ years’ experience working as a Human Factors Engineer/Leader in the Pharmaceutical, Biotechnology and/or Medical Device/Combination Products industries.
Drug/Device Combination product/Medical Device User Interface and HFE Execution experience.
Experience in providing user interface design recommendations including instructions for use, labeling, and device design support.
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.
Detail-oriented
Strong organizational skills and verbal/written communication skills
Highly motivated self-starter with a sense of ownership and willingness to learn
Thrive in a fast-paced, growing, and dynamic work environment
Ability to form partnerships with internal stakeholders
Seasoned soft skills (i.e., high EQ)
Technology savvy

Nice To Haves

Advanced Degree (e.g., Masters, PhD) preferred

Responsibilities

Support Kymanox Human Factors (HF) services in the development of HF strategies and execution of overall HF and Usability Engineering (UE) Programs with a focus on combination products and medical devices.
Serve as subject matter expert for Kymanox in HFE/UE, Human Factors Regulatory Strategy, and Risk Management
Serve as technical lead for multiple programs including combination products and medical devices
Lead specific client program efforts, including, but not limited to product lifecycle strategy consulting, supporting client development teams as primary HF/UE resource, planning and executing HF/UE activities and HF studies.
Support the HF analysis of new and existing medical products using sound research methodologies, best practices, and regulatory requirements
Support the planning, execution, and reporting of human factors research studies throughout the US and internationally
Design, development, protocol implementation, moderation, data analysis, and report writing of human factors activities; including formative and validation studies.
Lead the execution of human factors consulting projects for multinational and start-up companies.
Compliance with global regulatory agencies, especially FDA is mandatory. Participation as a consultant-team member working with other like-minded professionals with a passion to support our clients and provide safe and effective medical products and devices to professional and lay users.
Coach and support team members in areas of technical expertise and practical implementation.
Operate within defined QMS and business procedures.
Identify and evaluate process improvement opportunities.
Always be looking and listening for new opportunities to broaden and deepen our services within the medical products industry.