Human Factors Study Lead

I s Kymanox the right fit for you?

You want to make a difference and have an impact…

You enjoy having an influence in your day-to-day work…

You are motivated by working alongside a team filled with

subject matter experts who will help you learn and grow…

You wake up every day and do what you do

… because patients deserve better.

If this sounds like you, you’ve come to the right place.

Kymanox is hiring a Human Factors Study Lead to join our team.

Responsibilities
• Support the planning, execution, and reporting of human factors research studies throughout the US and internationally.
• Conduct data collection, analysis, and documentation to support development of regulatory strategy, road-map for medical device and combination product clients.
• Design, development, implementation, moderation, data analysis, and report writing of human factors activities; including formative and validation usability studies.
• Support the human factors analysis of new and existing medical products using sound research methodologies, best practices, and regulatory requirements
• Support client consulting efforts for multi-national and start-up companies , including, but not limited to product lifecycle strategy, supporting client development teams as primary HF/UE resource, planning and executing HF/UE activities and studies.
• Compliance with 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.
• Execute duties in a manner aligned to core values.
• 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 engineering or science with coursework or work-related experience in medical sales, business development, marketing, or communications. Advanced Degree (e.g., Masters, PhD) preferred.

Experience
• Minimum 3 years' relative experience with Medical Devices and/or Combination Products.
• Minimum 3 years’ relative experience with executing and moderating HF studies (formative or validation)
• Knowledge of IEC 62366-1, FDA guidance on Human Factors, and ISO 14+71
• Proficiency in MS Office Suite.

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 including interpersonal, coaching, and facilitation skills.
• A friendly, professional demeanor and ability to excel in a team-oriented environment.
• Strong attention to detail.
• Ability to travel in the US.