DUNEDIN, FL / ACCESSWIRE / May 30, 2023 / BlackHägen Design, a user-centered medical device development consultancy, is growing. With the expansion of their Human Factors Engineering team, they've appointed Renée Bailey as Senior Manager of Human Factors Engineering (HFE).
"With increasing complexity in the global regulatory landscape and related human factors engineering/usability engineering (HFE/UE) processes for medical research and device development, we are delighted to have Renée join us and bring her decade of experience in human factors engineering as well as 25 plus years as a Certified Instructional Technologist (CIT) and Performance Improvement Consultant," said Philip Remedios, BlackHägen's CEO, and Director of Design and Development.
Renee's extensive experience consulting and leading teams on high-profile, cross-functional programs include working in Fortune 100/500 organizations and diverse regulated industries including pharmaceutical and medical device manufacturing. Drawing from her experience, customers will benefit from her strategic approach to human factors programs, regulatory-focused human factors best practices, and the design of instructional user interfaces to support users effectively.
Drawing from Renée's experience consulting and leading teams on high-profile, cross-functional programs in Fortune 100/500 companies and diverse regulated industries, including pharmaceutical and medical device manufacturing, customers will benefit from her strategic approach to human factors programs, regulatory-focused human factors best practices, and design of instructional user interfaces to support users effectively.
"I am thrilled to be joining BlackHägen Design. They have an exceptional company culture focused on finding innovative solutions to complex problems. This position is a great fit with my background and expertise, and I look forward to applying BlackHägen's approach of integrating design and human factors to achieve the best results for our clients," said Renée Bailey, Senior Manager of HFE.
In addition to being an active member of the Human Factors and Ergonomics Society (HFES) and Regulatory Affairs Professionals Society (RAPS), Renée is also a co-author and former faculty for the AAMI workshop "Applying Human Factors to Instructional Materials as Part of the User Interface," the RAPS workshop "Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?" and contributing author to the book "Applied Human Factors in Medical Device Design."
About BlackHägen Design
Headquartered in Dunedin, Florida, BlackHägen Design is a multidisciplinary, user-research and product design firm supporting start-ups through Fortune 50 companies. Its pragmatic approach to product design is well-suited to safety-critical and environmentally challenging industries and has a long-standing history of serving those clients. At BlackHägen Design's core, user-centered processes drive innovation and sustainable product development. This systematic methodology for translating research insights into design requirements and creating valuable intellectual property has contributed to well over 100 patents and trade secrets over the last 28 years.
BlackHägen Design continuously optimizes the quality of its methodologies and services through rigorous deployment of its Quality Management System, which is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485, while easily adaptable to clients' in-house QMS for seamless documentation transfer. For more information visit: www.BlackHagenDesign.com
Ripple Effect Communications
SOURCE: BlackHagen Design