(Part-time Contract) Human Factors Study Lead - Combination Products

Human Factors Study Lead – Combination Products (Contract) Lead specific client consulting 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 studies. Support the human factors 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. Conduct data collection, analysis, and documentation to support regulatory submissions. Lead the execution of human factors consulting projects for multinational and start‑up companies. Compliance with regulatory agencies, especially FDA is mandatory. Design, develop, implement, moderate, analyze data, and write reports for human factors activities, including formative and validation usability studies. Participate as a consultant‑team member working with other like‑minded professionals to support 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 services within the medical products industry. Educational Background The ideal candidate will have a bachelor’s degree in engineering or science (or relevant degree). Advanced Degree (e.g., Masters, PhD) preferred. Experience Minimum 3 years’ relative experience with executing and moderating HF studies (formative or validation). Minimum 3 years' relative experience with Medical Devices and/or Combination Products. Knowledge of IEC 62366‑1, FDA guidance on Human Factors, and ISO 14971. Proficiency in MS Office Suite. Experience with product design and development, quality, and regulatory submissions is a plus. Desired Aptitude and Skill Set Ability to prioritize, plan, perform and communicate activities both in written and verbal form. Ability to read and understand published regulations. Ability to present analysis and evaluation results in a cohesive, understandable, and actionable format to cross‑functional teams and decision‑makers. Ability to communicate well at all levels of the organization. Ability to work effectively cross‑functionally. Strong problem‑solving skills. Strong prioritization skills. Excellent communication skills include interpersonal, coaching, and facilitation skills. A friendly, professional demeanor and ability to excel in a team‑oriented environment. Strong attention to detail. Travel Up to 50% travel. 30‑50 hours per week when traveling. Kymanox is an equal‑opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry. #J-18808-Ljbffr Kymanox Corporation