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Principal Software Requirements Engineer

2 months ago

Minnesota Lake, United States Critical Fit Recruiting Full time

RESPONSIBILITIES: Lead the design, development, and implementation of software for class-3 medical devices for both new products and sustaining activities on post market products. Work with cross-functional teams to define and refine software subsystem requirements and specifications based on system requirements and user needs. Play a critical role in the development of IEC 62304 compliant medical device software for new products as well as adding improvements to the existing product line. Develop and maintain software requirements, specifications, design documents, test protocols, and reports in alignment with IEC 62304. Participate in risk assessments and ensure risk management processes are followed throughout the software development lifecycle. Introduce innovative solutions to enhance the performance, reliability, and capability of our software products. Conduct code reviews and ensure compliance with internal SOPs, best practices, and adherence to regulatory requirements and industry standards (e.g., IEC 62304 SDLC, ISO 13485 Quality Management System, ISO 14971 Risk Management, etc.). Perform software verification and validation activities, including unit testing, integration testing, and system testing. Collaborate with hardware engineers to integrate software with medical device hardware components. Work closely with quality assurance and regulatory affairs teams to prepare and submit documentation for regulatory approvals. Coach and mentor junior software engineers and provide technical leadership. BACKGROUND PROFILE: Minimum of a Bachelors degree in Electrical Engineering, Software Engineering, Computer Science, or a closely related field. Minimum of 6 years of experience in software development for medical devices, with a focus on class-2 and class-3 devices. Strong understanding of IEC 62304 and other relevant standards (ISO 13485, ISO 14971, etc.). Proficiency in programming languages such as C/C++, Python, or Java. Familiarity with embedded systems, communication protocols, and real-time operating systems. Previous experience with cloud-based solutions for medical devices a plus. Wide knowledge of software development methodologies and best practices, including unit and integration test frameworks. Experience with software development tools (IDEs, version control, issue tracking). Familiarity with cybersecurity principles in the context of medical device software. Ability to make critical judgments and decisions, to hold technical leadership roles, to understand root causes of technical problems encountered, and execute thorough completion of documentation associated with work product. Strong interpersonal, communication, and technical writing skills, with the ability to work in a dynamic, multi-lingual environment. Ability to build cross-functional relationships across the organization where persuasive skills, negotiation expertise, and considerable tact are required to gain support.