In this role, you have the opportunity to
Establish and maintain agile product development systems to support requirements engineering, risk management, and product verification for hardware and software medical devices and components.
You are responsible for
Elicit, review, and characterize stakeholder feedback; create and review system-user interaction models using BPMN, UML, or SysML.
Develop and document use cases, user stories, and usage scenarios to support the definition of user, system, and product requirements for each stage of the system lifecycle.
Develop enterprise system requirements and master validation plans.
Establish and maintain continuous integration and test engineering systems to support the development, verification, and validation of medical device products and components.
Establish automated test systems for medical device products and components.
Create and maintain software validation records for enterprise tools and systems used in the development and qualification of medical device products, including system design, requirements, protocols, and reports.
Create and maintain validation project plans.
Perform risk identification, analysis, planning, and verification activities in accordance with ISO 14971.
Create change impact analyses to support system development, verification, and validation planning. Create verification reports, validation reports, and other documentation to support the product development and design transfer processes.
You are a part of
Invivo Corporation, a subsidiary of Philips Healthcare and world leader in MRI coils and related accessories, is looking to expand its Gainesville, FL team. Our vision is to deliver clinical solutions to our customers, whether indirectly through Original Equipment Manufacturers of MRI scanners, or directly to clinical MRI users. Our history is grounded in the expert development of MRI coils and more recently in the development of integrated clinical solutions like Functional MRI and the DynaCAD breast imaging system. Research and advanced development are at the core of the future of the MRI field and are a key part of Invivo's strategy for growth.
To succeed in this role, you should have the following skills and experience
Bachelor degree in Computer Science, Engineering or equivalent and 3+ years of related systems design experience
Experience with software development in a regulated industry
Excellent communication skills, both verbal and written
In return, we offer you
To advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
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.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.