Agilis Consulting Group is one of the fastest growing human factors firms serving the pharmaceutical and medical device industry (www.agilisconsulting.com). Agilis is a trusted human factors partner for the global medical market. We help new and established companies achieve successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical devices and combination products. Agilis’ proven human factors strategies, process and expertise drive regulatory success and speed to market – the first time.
We are seeking a human factors engineer with 510(k), PMA, 21CFR820 or ISO 14971 experience who is a team player, has a passion for quality, and enjoys working with a selective client base on an interesting variety of medical products and devices in a fast-paced environment. If you love human factors engineering and working in a collaborative team environment – this may be the right fit.
Advanced degree in human factors, biomedical engineering or related field and 3+ years of experience preferred, or equivalent combination of education and human-research experience. Experience with medical devices or pharmaceutical products is required. Excellent verbal and written communication skills are crucial as well as demonstrated proficiency with Excel. Access to a stable internet connection is also required. No visa sponsorship is available for this position.
Telecommuting is allowed.
About Agilis Consulting Group
We focus on one thing – results for our medical device and drug delivery clients. Agilis helps clients achieve FDA clearance with less costly bureaucratic delays and improved human factors/validation study results. We accomplish this by applying our proprietary methods and expertise in human factors and FDA human factors regulatory requirements to the submission process. We know that the shortest distance between submission and clearance is understanding FDA expectations and guidelines. We do. What makes us unique is that we look at all the factors necessary for success: understanding the FDA regulatory requirements; expertise in human factors; and demonstrated proficiency in labeling and training.