Danaher Corporation Staff Human Factors/Quality Assurance Engineer in Miami, Florida
Danaher Company Description
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
This position will: Provide Human Factors/Usability Engineering expertise, design control quality compliance, risk management and design validation leadership on medical device new product development programs and function as the representative of all quality functions on the programs. Serve as an expert/coach in Human Factors/Usability Engineering for new product development and design change programs and consults with other departments on scientific processes, product and process improvement, and new product development. Provide key input to technical decisions by systems analysis of interacting effects of designs and processes. Prepare and issues assigned quality reports. Determine and/or recommend direction taken in technical product or manufacturing issues. Recommend design, review and/or approve experiments. Review and/or comment on technical content of intra and interdepartmental reports. Provide design review and risk assessment expertise.
The qualified candidate will ideally be certified in Human Factors Engineering for Medical Devices and Quality Engineering, and be able to demonstrate leadership capability and skills necessary to work across multiple departments, and development teams, to ensure optimal application of quality practices.
Experienced Human Factors and Quality Engineering professional with a baccalaureate college degree in Bioscience or Engineering and at least 10 years of relevant experience in the regulated medical device/diagnostics industry. Human Factors Engineering certification, Quality Engineering certification, Graduate degree and in vitro diagnostics experience preferred.
Proven expertise with interpreting, applying, and leading others in compliance with the following current standards; IEC/EN 62366 Application of Usability Engineering to Medical Devices, ANSI HE75 Human Factors Engineering in Design of Medical Devices, USFDA Quality System Regulations for Medical Devices; EU IVD/MD Directives, ISO 13485 Quality Standard, and ISO 14971 Risk Management Standard.
Proven expertise in medical device design controls including; experimental design, design validation and risk management.
Proven experience in project management/leadership of teams and teambuilding.
Knowledge of the pre and post-market Quality aspects of the medical device product lifecycle.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries. A globally diverse team of 81,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2015, we generated $20.6B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20yrs.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Beckman Coulter
Job Function: Quality
Primary Location: North America-United States-FL-Miami
Req ID: BEC005633