ACCESSWIRE
30 May 2023, 23:05 GMT+10
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
Media Contact:
Dawn Fontaine
Ripple Effect Communications
[email protected]
617-536-8887
SOURCE: BlackHagen Design
Get a daily dose of The US News news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to The US News.
More InformationWARSAW, Poland: As part of European Union (EU) sanctions imposed against Russia over its invasion of Ukraine, Poland banned all ...
MONTGOMERY, Alabama: Last week, Alabama's school chief, Superintendent Eric Mackey, said that under new reading benchmarks to move to fourth ...
WASHINGTON D.C.: Last week, the Federal Reserve said its losses surpassed the US$100 billion mark and will likely continue to ...
ARLINGTON, Virginia: This week, the U.S. State Department approved the potential sale of drone-related munitions and other systems to Canada ...
BETHESDA, Maryland: This week, the US National Institutes of Health (NIH) said that it started early-stage human trials on FluMos-v2, ...
MAUI, Hawaii: Hawaii Governor Josh Green has announced that the death toll from last month's deadly fire on Maui has ...
NEW YORK: This week, the Wall Street Journal (WSJ) reported that U.S. electric vehicle (EV) maker Tesla and Saudi Arabia ...
NEW YORK, New York - Interest rates could stay higher for longer, but there is the possibility of rate cuts ...
STOCKHOLM, Sweden: Days before the Riksbank, Sweden's central bank, is expected to again raise interest rates, the Swedish krona hit ...
NEW ORLEANS, Louisiana: As Midwest farmers prepare to harvest crops and send tons of grain downriver to the Gulf of ...
JAKARTA, INDONESIA: Government data released this week showed that as imports, such as raw materials and capital goods, declined more ...
NEW YORK, New York - U.S. investors fretted Tuesday while the U.S. central bank deliberated on whether to hike interest ...