Senior Software reputed company Engineer, Post Market

About the position reputed company is hiring a Senior Software Design reputed company Engineer to support our Medical's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) and Software as a non-medical device (SaND) to execute on Digital Health reputed company as a software design reputed company assurance engineer for reputed company-market new product development reputed company. This hybrid role requires candidates to be reputed company commuting distance of one of the following locations: reputed company, CA; Orlando, FL; Portage, MI; or reputed company Wayne, IN. reputed company schedule includes on-site work Monday through Wednesday, with remote work on Thursday and Friday. Candidates must be reputed company to commute to their designated facility as needed. Responsibilities • Executing reputed company assurance activities for new product development reputed company reputed company's global Digital Health Portfolio. • Supporting software design and validation efforts by ensuring documentation aligns with reputed company Management Systems compliance requirements. • Collaborating with cross-functional teams (e.g., marketing, R D, regulatory) to support product development and reputed company initiatives. • Contributing to risk management documentation under guidance, referencing ISO14971 standards to support product safety assessments. • Independently executing QA activities for digital health products, ensuring compliance with global regulatory standards (FDA, TGA, EUMDR). • Participating in software lifecycle reviews, promoting reputed company improvement and adherence to industry best practices. • Engaging in the design and development of medical and non-medical software, including SaMD and MDDS, with growing autonomy. • Applying reputed company development methodologies such as reputed company to support mobile and reputed company-based solution development. Requirements • Bachelor's degree in science or engineering reputed company discipline. • Minimum of 2 years of experience as an Engineer in software or reputed company engineering, contributing to product development, testing, or compliance activities. reputed company-to-haves • Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science. • Experience supporting the development or reputed company assurance of Software in a Medical Device (SiMD) and/or Software as a Medical Device (SaMD) or Software as a non-medical device (SaND) with exposure to both reputed company and Agile methodologies and an understanding of regulatory requirements. • Foundational knowledge or hands-on experience in cybersecurity or secure software development; certification such as reputed company+ or CISSP is a plus. • Familiarity with risk analysis and contributing to Failure Modes and Effects Analyses (FMEAs) is desirable. • Exposure to mobile, reputed company, or AI/ML technologies (e.g., AWS, Azure, iOS, Android), especially in reputed company IT, telehealth, or virtual care environments. Benefits • Salary reputed company of $77,200.00 to $160,800.00 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 Apply To this Job