Philips Usability Validation Engineer in Monroeville, Pennsylvania
In this role, you have the opportunity to work under direct supervision of the V&V Lead to produce clear and concise validation documents for medical devices. Your focus will be designing and conducting usability test programs in accordance with IEC 62366-1 and FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” in conjunction with ISO14971.
You are responsible for
Develop usability test plans.
Develop formative evaluations, test protocols, conduct testing, and write reports.
Assist with the identification of use specifications, use errors, and usability risks.
Develop summative evaluations, test protocols, conduct testing, and write reports.
Assess test results and usability risks for acceptability with the development team.
Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, and Forms).
Provide weekly project status reports.
Prioritize project tasks to complete on schedule while maintaining quality of work.
Work in a team environment; peer review work.
Work on multiple, concurrent projects
Develop V&V test plans, test protocols, and test reports.
Review requirements and scrutinize for testability.
Assess designs of products against design input requirements.
Execute test procedures both personally and supervising test technicians.
Log defects and issues found during V&V activities and track to closure.
Perform regression analysis and determine testing associated with design changes.
You are part of
This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech.
Our vision is to work hand-in-hand with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.
Skills and experience
Bachelor’s Degree in an engineering discipline. Degree in Usability Engineering, Industrial Engineering or Human Factors Engineering preferred.
2+ years professional experience implementing usability engineering techniques on medical devices.
Basic understanding of global medical device regulations, requirements, and standards preferred.
Working knowledge of the following International Standards and Guidance Documents highly preferred:
IEC 62366-1:2015 – Application of usability engineering to medical devices
FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices – February 19, 2016”
ANSI/AAMI HE75:2009 – Human factors engineering – Design of medical devices
ISO 14971:2007 – Application of risk management to medical devices
We offer you
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.