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Full-Time

Senior Human Factors Engineer

Contract

Posted on 6/27/2024

THRIVE

THRIVE

51-200 employees

Designs health product experiences, utilizes agile principles

Consulting

Senior, Expert

Atlanta, GA, USA

Category
Healthcare Administration & Support
Nursing & Allied Health Professionals
Medical, Clinical & Veterinary
Required Skills
Communications
PowerPoint/Keynote/Slides
Requirements
  • 5+ years of experience in a relevant role
  • Experience preparing a usability file for FDA submission and experience submitting to other regulatory agencies is a plus
  • In possession of a relevant degree or professional qualification(s) (Human Factors Engineering, Human-Computer Interaction, Industrial Design, Cognitive Psychology)
  • Medical Device experience is a requirement
  • Experience working directly with healthcare stakeholders (HCP’s, patients, etc.) to gather, synthesize and convert user research into actionable recommendations that drive compelling designs
  • Experience working directly with end users to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring satisfaction
  • Proven experience in the HFE/UE principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/reporting/analysis
  • Strong knowledge of relevant human factors regulations, standards and guidance for physical and digital medical devices and pharmaceutical packaging
  • Good understanding of the principles of Medical Device and healthcare regulations including FDAs Quality System Regulation (QSR), IEC 62366, IEC 14971, IEC 60601, HE 75, MDR
  • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines
  • Proven experience using low through high-fidelity prototypes (physical and digital) to identify and eliminate potential use errors early in the development process
  • Comfortable working in a very creative, fast-paced, and rapidly changing environment
  • Experience facilitating client experiences through workshops and collaborative work sessions
  • Working knowledge of Microsoft Office, PowerPoint, Visio, Excel, Adobe Photoshop, Illustrator, InDesign
  • Excellent writing and speaking skills
Responsibilities
  • Serve as a Senior Human Factors Engineer and project lead on multiple healthcare/medical device research projects, product development programs, and other design programs
  • Assume responsibility for executing key project activities, creating deliverables, and delivering projects on time and on budget
  • Combine appropriate research methods, theory and content that address the client’s business challenges
  • Support the HFE team as needed with the planning and execution of usability tests, both formative and summative
  • Develop research materials, such as protocols, moderator guides, and data collection instruments and assumes responsibility for collecting research data in various formats
  • Collaborate with interdisciplinary teams of researchers, industrial designers, and engineers to develop the best solution for the client
  • Synthesize complex information from multiple data sources into clear and actionable insights, frameworks, requirements, and documentation assets
  • Structure and facilitate collaborative multi-stakeholder client workshops that inspire clients and generate actionable outcomes at various points in the product development process
  • Collaborate closely with clients to build and maintain strong relationships and client satisfaction
  • Utilize and further develop state-of-the-art protocols, standards, systems, and research methods
  • Author documentation compliant to relevant standards for client medical device development programs
  • Deliver compelling verbal, written, and visual communications
  • Credibly lead presentations with senior executives and client teams

THRIVE is a strategic design firm that specializes in creating innovative product experiences in the health and well-being sector. The firm integrates deep empathy and sharp strategic insight to develop solutions that not only meet but anticipate the needs of consumers and clients. By applying agile principles and focusing on human understanding, this company provides a dynamic and supportive working environment that encourages growth and innovation among its employees.

Company Stage

N/A

Total Funding

N/A

Headquarters

Detroit, Michigan

Founded

2009

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
INACTIVE