Medical Devices & Diagnostics Global Services, LLC, a division of the Johnson & Johnson Family of Companies, is recruiting for a Senior Software Engineer, Commercial Operations Medical Devices NA. This position can be located in Morrisville, NC, Santa Ana, CA, Jacksonville, FL or Fort Washington, PA.
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 & Diagnostics Global Services, LLC 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 Medical Device 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.
Provide technical requirements, coding, testing, and troubleshooting within manufacturing at external manufacturers (EM’s) as well a post-production and any associated component suppliers on a routine basis. Will be the liaison for the transfer of medical devices from R&D into the EM’s and associated component suppliers. Position requires excellent knowledge of OS coding techniques and hands-on development of production procedures within an FDA cGMP and ISO 13485 medical device quality system to improve manufacturing productivity, yields, and reduce product costs. Position will work across multiple products to provide a high degree of product availability/yields, quality and reduce cost
of goods sold.
Design, develop, code, test and debug system software
Review code and design
Develop solid and efficient test tools and procedures
Analyze and enhance efficiency, stability and scalability of system resources
Work closely with QA in developing QA compliant procedures related to the software design, implementation and verification. Ensure this is consistent with the company Data Management System
Ensure the engineering documents produced are checked and approved in compliance with the applicable procedures/checklists
Optimize I/O performance of all Capital Products
Provide software support to EM’s and post production (Service) and key related component suppliers
Interface with hardware design/development personnel
Assess third party and open source software
Create new processes and documents within production procedures as required for FDA Good Manufacturing Practices (cGMP) and ISO 13485 cGMP.
Travel (<10% and might involve international travel)
Experience in embedded software development and trouble-shooting using C/C++
Excellent knowledge of OS coding techniques, IP protocols, interfaces and hardware subsystems
Familiarity with software configuration management tools. Defect tracking tools, and peer review
Demonstrated expertise and experience integrating hardware and software systems
Understanding of embedded hardware and architectures
Familiarity using Product Life Cycle (PLM) applications
Strong documentation and writing skills
Proficient in Microsoft Office
Excellent understanding and experience with FDA, cGMP, ISO medical device regulatory requirements relative to Class II 510K medical devices.
BS in Computer Engineering, Computer Science or related with minimum five (5) years’ experience
Successful track record of manufacturing in a high tech (Medical Device preferred) environment (work with EM’s and associated component suppliers is a plus).
United States-North Carolina-Morrisville
North America-United States-California-Santa Ana, North America-United States-Pennsylvania-Fort Washington, North America-United States-Florida-Jacksonville