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KKR Consulting • Massachusetts, United States
Salary: 21 CFR Pa
KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients d
KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.
Job Title: Software Design Quality Engineer
Location: Danvers, MA
Job Summary SiMD/SaMD Development. The role is going to be focused on a New Product Development program that incorporates both Firmware and the main system software components. Specifically on the firmware side, the consultant will be working closely with our firmware team in Germany. They have a lot of critical programs in parallel due to FDA activities. AIC- 6 parallel programs: some SW(4), some HW(2). There is a need for an additional SW DQE headcount to support clients' next gen program.
This consultant will be focused on both Firmware and the EPC (Embedded Personal Computer) and will be heavily involved early in the development process. The focus is on driving design quality during the design & development of the program to ensure all changes are fully documented and compliant.
Key Responsibilities The program they will be supporting is a next gen console initiative, with responsibility spanning both Firmware and the EPC (main system software). Support early-phase development activities, including design quality planning and execution Support design changes through the CCB process, ensuring updates are compliant with 21 CFR Part 11, 524B, and IEC 62304 Support sprint cycles and daily SCRUM They will be supporting risk management activities of the product Reviewing test protocols and reports Conduct SW Code reviews Conduct design reviews Support cyber risk assessments They may be involved in planning activities for sprint cycles