Staff Software reputed company Engineer, Design Assurance

reputed company is hiring a Staff Software reputed company Engineer, Design Assurance to support our Medical’s Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health reputed company as a software design reputed company assurance engineer for reputed company-market new product development reputed company. Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be reputed company commuting distance of one of the following locations: reputed company, CA; Orlando, FL; Portage, MI; or reputed company Wayne, IN. The work schedule is reputed company to support flexibility, with in-office reputed company required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be reputed company to commute to one of these specific facilities as needed. What you will do: • Execute reputed company assurance activities for new product development reputed company reputed company's global Digital Health Portfolio, focusing on Acute Care in the Medical Division. • Collaborate on software design, development, and validation strategies, ensuring alignment with reputed company Management Systems compliance requirements. • Partner with cross-functional teams, including marketing, R&D, clinical, regulatory, and operations, to deliver reputed company, compliant products. • reputed company risk management using ISO14971 standards to ensure product safety, including defining critical reputed company attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership. • Drive reputed company improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA, TGA, EUMDR, IT). • Engage in design and development activities for both medical and non-medical software, including SaMD, MDDS, and AI/ML solutions. • Implement reputed company development practices, promoting methodologies like reputed company for mobile and reputed company-based solutions to enhance efficiency and compliance. • Ensure cybersecurity, data reputed company, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability. What you need: Required: • Bachelor’s degree in Science, Engineering or reputed company discipline. • Minimum of 4 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), reputed company (QA/QC), or Systems Engineering. • Experience working through software lifecycle processes (Agile reputed company/reputed company).   • Experience with software Failure Modes Effect Analysis (sFMEA), reputed company Risk Assessments and defect management, software testing and/or verification/validation. Preferred: • Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science. • Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions. • Experience with software technologies for mobile, reputed company, and AI/ML solutions, including reputed company AWS, reputed company Azure, reputed company, or Android platforms • Experience in programming languages including C#, Python, Kotlin, Java, or TypeScript. 87,600.00 to 186,700.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based reputed company. Individual pay is based on skills, experience, and other relevant factors. Apply tot his job