Principal Software Systems Engineer

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RESPONSIBILITIES : Lead the design, development, and implementation of software for class-3 medical devices, including new products and sustaining activities on post-market products. Collaborate with cross-functional teams to define and refine software subsystem requirements and specifications based on system requirements and user needs. Develop IEC 62304 compliant medical device software for new products and improve existing product lines. Create and maintain software requirements, specifications, design documents, test protocols, and reports in accordance with IEC 62304. Participate in risk assessments and ensure risk management processes are followed throughout the software development lifecycle. Introduce innovative solutions to enhance software performance, reliability, and capabilities. Conduct code reviews, ensuring compliance with internal SOPs, industry standards (e.g., IEC 62304 SDLC, ISO 13485, ISO 14971), and regulatory requirements. Perform software verification and validation activities, including unit, integration, and system testing. Collaborate with hardware engineers for software integration with medical device hardware. Work with quality assurance and regulatory teams for documentation related to regulatory approvals. Coach and mentor junior engineers, providing technical leadership. BACKGROUND PROFILE : Bachelor's degree in Electrical Engineering, Software Engineering, Computer Science, or a related field. At least 6 years of experience in software development for medical devices, especially class-2 and class-3 devices, with a strong understanding of IEC 62304 and relevant standards. Proficiency in programming languages such as C/C++, Python, or Java. Experience with embedded systems, communication protocols, real-time OS, and cloud-based solutions is a plus. Knowledge of software development methodologies, test frameworks, development tools, and cybersecurity principles for medical device software. Ability to make critical decisions, provide technical leadership, analyze root causes, and complete documentation thoroughly. Strong communication, technical writing skills, and ability to work in a multi-lingual, dynamic environment. Skill in building cross-functional relationships, negotiation, and tactful support across the organization.
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Location:
Minneapolis, MN, United States
Category:
Computer And Mathematical Occupations

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