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

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.
• Lead the execution of human factors consulting projects for multi-national and start-up companies.
• Compliance with regulatory agencies, especially FDA is mandatory.
• Design, development, implementation, moderation, data analysis, and report writing of human factors activities; including formative and validation usability studies.
• 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.

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.