J&J Family of Companies IT Senior Manager, SaMD Product Manager in Warsaw, Indiana
Medical Devices, a division of the Johnson & Johnson Family of Companies, is recruiting for a Software as a Medical Device (SaMD) Product Line Owner. This position can be located at any J&J operating site; however, a strong preference will be given to those located Cincinnati, OH, West Chester, PA, Warsaw, IN and Raritan, NJ. This role reports to the IT Product Technology Innovation Product Line Owner.
As the world’s most comprehensive medical devices business, J&J Medical Device Companies are building on a century of experience, merging science and technology, to craft the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.
The Product Technology Innovation Team places a large emphasis on improving individual strengths to not only accelerate delivery but propel career growth forward. As a team, we are committed to encouraging a supportive environment and will provide many opportunities for learning new skill sets. We invite you to be part of our lasting impact on patient lives by joining a ground-breaking team in the world of surgical innovation.
The Product Line Owner will:
Analyze science, engineering, business, and other data processing problems to implement and improve computer systems
Analyze user requirements, procedures, and problems to automate or improve existing systems and review computer system capabilities and workflows
Assist the R&D Innovation team with formulating and implementing global vision, strategies, and roadmap execution of J&J’s SaMD platforms
Partner with the R&D Product Development organizations to understand their SaMD needs, help prioritize investments, develop use cases, generate processes, and develop overall solution requirements including application definition, integration, security, hardware, and system configurations
Understand the end-to-end process for the systems related to new product development and process engineering of these new businesses
The candidate will have an entrepreneurial approach, excellent communication skills, and comfortable adapting communications to the appropriate audience (eg: executive management, software developers, etc.)
This candidate will be a passionate change agent and capable of driving the technology strategy across J&J Medical Devices
Analyze and recommend commercially available software product, review strategic IT planning and advise management to ensure agreement
Test, maintain, and supervise computer programs and systems, including coordinating the installation
Develop, document and revise system design procedures, test procedures, and quality standards
Provide staff and users with assistance to tackle computer related problems, such as malfunctions and program problems and identify appropriate and/or alternative solutions.
A minimum of a Bachelor’s degree in the field of computer science, engineering or a related technology field or 8+ years of practical work experience in IT
Experience delivering Class I, Class II, and Class III FDA regulated medical devices
A minimum of 5 years of program management experience
Experience executing projects following FDA software design controls (IEC 62304)
Experience delivering GxP validated software applications
Solid understanding of software development/engineering
Experience delivering IT projects utilizing the Agile SCRUM methodology
Experience crafting processes and documenting requirements
With little supervision, be able to define, shape, and drive projects to completion while optimally collaborating strategically with others
Good understanding of business value and capabilities and ability to relate priorities to associated technology investments
This role may require up to 15% travel, domestic and international
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Ohio-Cincinnati-4545 Creek Road
North America-United States-Indiana-Warsaw, North America-United States-Pennsylvania-West Chester, North America-United States-New Jersey-Raritan
Johnson & Johnson Services Inc. (6090)
J&J Family of Companies
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