Johnson & Johnson Careers
IT SaMD Product Line Owner
Requisition ID: 0718180828
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. This role reports to the IT Product Technology Innovation Product Line Owner.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Medical Devices represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD organization supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
- 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 ideal candidate will have an entrepreneurial mindset, 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 consult with management to ensure agreement
- Test, maintain, and monitor computer programs and systems, including coordinating the installation of computer programs and systems
- Develop, document and revise system design procedures, test procedures, and quality standards
- Provide staff and users with assistance to solve 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
· Experience executing projects following FDA software design controls (IEC 62304)
· Experience delivering GxP validated software applications
· Strong knowledge of software development/engineering
· A minimum of 5 years of program management experience
· Experience delivering IT projects utilizing the Agile SCRUM methodology
· Experience creating processes and documenting requirements
· With little supervision, must be able to define, shape, and drive projects to completion while effectively collaborating strategically with others
· Good understanding of business value and capabilities and ability to relate priorities to associated technology investments
Depuy Orthopaedics. Inc. (6029)