Philips Senior Systems Engineer in Gainesville, Florida
Establish and maintain agile product development systems to support requirements engineering, risk management, and product verification for hardware and software medical devices and components.
• 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.
We have a dynamic and rewarding career opportunity for Senior Systems Engineer in Gainesville, FL.
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.
At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care.
Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
Bachelor degree in Computer Science, Engineering or equivalent and 3-6 years of related SW design experience
Experience developing web-based applications
Experience with software development in a regulated industry
Experience with graphics programming
Experience with database design
Excellent communication skills, both verbal and written
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.