Senior Medical Device Human Factors Consultant

Job Description

Looking for the opportunity to have a direct impact on the usability and innovative aspects of medical device solutions?

A client is seeking a dynamic and highly-independent Human Factors professional to directly engage medical device manufacturers in the definition and validation of end user requirements. The role will also provide the opportunity to validate solution requirements and designs with end users in real-world settings. Key insights, along with other considerations, like FDA requirements, are synthesized and articulated in design recommendations presented.

**Only Charlotte, NC based candidates with Human Factors experience will be considered**

Reporting to the Senior Technical Director, the Senior Consultant will be responsible for:

• Planning, developing and performing usability evaluation activities for medical devices at all stages of the development life-cycle for one or more projects
• Conducting human factors analyses of medical devices utilizing the client’s defined methodology
• Validating requirements and design solutions with customers and prospective medical device users
• Planning, leading, and participating in customer engagements aimed at validating compliance with Human Factors Guidelines
• Analyzing and interpreting data from human factors studies
• Documenting and presenting user research, evaluation plans, and study findings, and recommendations to customers

Qualifications

Required Skills (only candidates meeting these requirements should apply):

• Graduate degree in Human Factors or a related discipline

• Effective project management skills with proven ability to work independently and multi-task

• Demonstrated customer-management skills

• Excellent written and verbal communication skills; strong presentation skills and technical writing ability

• Strong analytical and problem-solving abilities; detail-oriented, self-driven, fast-learner

• Ability to travel to customer sites and healthcare facilities throughout North America

Preferred Skills:

• 7+ years’ experience in defining, preparing, and conducting formative and summative human factors studies

• Working knowledge of human factors standards and guidelines, including HE75, CR 820.30, and IEC62366 as they apply to the design and evaluation of medical devices, including requirements for compliance with human factors requirements for different regulatory bodies, particularly those of the FDA

• Minimum 2+ years of professional experience in medical product development

 Market salary and benefits align with experience.

Interested in exploring this medical human factors opportunity, please send current resume, in PDF format, to Dana at dana@onesource-nc.com or call 919-604-6800 for a confidential conversation.

Everything starts with a conversation!