Principal Human Factors Engineer

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 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.
• 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.

Educational Background

The ideal candidate will have a Bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering. Advanced Degree (e.g., Masters, PhD) preferred.

Experience

• 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.

Desired Aptitude and Skill Set

• 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

Travel

This role is based at our King of Prussia, PA on a hybrid schedule of 2–3 days on-site per week. Up to 5% domestic travel is possible.