Updated Sr. Software Design Engineer R and D Hybrid ...

The Sr. Software Design Engineer is responsible for the design, development, verification, validation, and documentation of embedded software for a Class I and Class II medical device and to act as a subject matter expert (SME) in software. The engineer will leverage their experience and knowledge in developing software within the relevant regulatory frameworks and processes. Experience working independently and collaboratively to plan, execute, and monitor project timeline goals to achieve milestones for multiple concurrent projects. This position follows a hybrid schedule model of work (Tues/Thurs in office). Responsibilities include: Responsible for developing, testing, debugging an embedded software for Class I and Class II medical devices as a Subject Matter Expert (SME).Generate, review, and approve the necessary documents related to the medical device SW (software planning, software development plan, software requirements, design specification, architecture, development and implementation, unit and integration plan and tests, software verification, defect resolution, maintenance activities, and risk management documents)Strong ability to work with internal technical team, deliver products per requirements as well as a strong ability to efficiently manage multiple projects at the same time is required.Manage product development projects and timelines and balance corporate priorities to ensure that deadlines and goals are met.Participate in code reviews applying design principles, coding standards and best practices.Develop protocols and reports for the verification and validation of the SW embedded devices.Develop and implement processes to define and establish functional and system performance of the software development life cycle.Review existing products and recommend improvements based on existing complaints, risk analyses, manufacturer feedback, vestigate root causes and provide corrective actions on product failures. Work with manufacturers to implement corrective actions if necessary.Consult the divisions to support any SW development projects.Support design transfer to manufacturing sites and new product implementation process.Requirements include: COVID-19 VaccinationPlease be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.Bachelor''s degree software engineering. Will consider a degree in electrical engineering with applicable industry experience in software programming. At least 4 years of experience in firmware and architecture development.Willing to travel up to 10% of the time for business purposes (domestic and international).Preferred Requirements include: Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.Experience with Medical device SW - Lifecycle processes: IEC 62304Familiar with FDA guidance with Digital Health content (GPSV)Familiar with source control program (Git) and unit testing framework (Unity, CppUTest, Parasoft C/C++Test)Experience utilizing Keil MDK, ARM development, STM32 C/ C++Familiar with AVR development Familiarity communicating design and architecture with Visio.Basic understanding of electrical circuit and hardware-related development and design.

Created: 2025-10-04