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

Is Kymanox the right fit for you?

Responsibilities

• 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 compliance.
• Lead the execution of human factors consulting projects for multi-national and start-up companies.
• Design, development, implementation, moderation, data analysis, and report writing of human factors activities; including formative and validation usability studies.
• Participate 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.

Requirements

• The ideal candidate will have a bachelor’s degree in engineering or science (or relevant degree).
• An advanced degree (e.g., Masters, PhD) is preferred.
• A minimum of 3 years’ relative experience with executing and moderating HF studies (formative or validation).
• A minimum of 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.

Qualifications

• 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.

Skills

• 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.

About Kymanox

Kymanox is a life sciences professional services company dedicated to helping life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible. Kymanox provides professional services related to engineering, compliance, and project management, servicing clients ranging from Fortune 100 companies to virtual start-up companies. Founded in 2004, Kymanox is headquartered in Research Triangle Park (RTP), North Carolina, with additional offices in King of Prussia, Pennsylvania, Switzerland, and Germany. Kymanox is an equal-opportunity employer committed to protecting the rights of job seekers through local, state, and federal laws and best HR practices in the Life Science industry.