AI Software Lead - Capital Equipment

An innovative medical technology company is seeking an AI Software Engineer to lead software development and regulatory compliance efforts for the expansion of a novel therapeutic platform. This role combines software engineering leadership,

IEC 62304

documentation ownership, and program execution. The successful candidate will help transition early-stage software systems through development, verification, validation, and commercialization while working closely with multidisciplinary engineering, quality, and regulatory teams. As the initial hire for the software team, this role offers the opportunity to build and lead a software engineering team as the program matures and scales. This is a great chance for senior engineers and managers to work with a passionate group and build upon commercial success within a fast-paced, cutting-edge environment. What You'll Do Software Quality & Regulatory Compliance Lead software compliance activities in accordance with IEC 62304 and related medical device regulations. Conduct software gap assessments and establish software safety classifications. Develop and maintain key software lifecycle documentation, including: Software Development Plans Software Requirements Specifications Software Architecture Documentation Traceability matrices Design and risk management documentation Partner with Quality and Regulatory Affairs teams to support global regulatory submissions. Own software risk management activities aligned with ISO 14971 and IEC 62304. Create and maintain software verification and validation strategies and plans. Lead software testing efforts across unit, integration, and system levels. Manage defect tracking, regression testing, and release readiness activities. Collaborate with human factors and safety teams to identify and mitigate software-related risks. Drive software project planning, scheduling, and milestone execution. Identify program risks, dependencies, and resource needs. Communicate progress and project status to cross-functional stakeholders and leadership. Oversee software contractors and external development partners when applicable. Team Development & Technical Leadership Help define and build a high-performing software engineering organization. Participate in recruiting, onboarding, and mentoring software engineers. Establish scalable development processes and engineering best practices. Partner with technical teams to translate clinical and system requirements into software specifications. Provide technical guidance on architecture, implementation, and compliance strategy. Required Qualifications Bachelor's or Master's degree in Software Engineering, Computer Science, Electrical Engineering, or a related discipline. 10+ years of software development experience. 5+ years of experience developing software for regulated medical devices. Hands‑on experience with IEC 62304 software lifecycle processes and documentation. Strong understanding of ISO 14971 risk management principles. Experience leading software verification and validation activities. Familiarity with modern software development tools, version control systems, DevOps practices, and requirements/risk management platforms. Demonstrated project leadership experience in complex technical environments. Experience mentoring engineers or leading technical teams. Excellent written communication skills and ability to produce audit- and regulatory‑ready documentation. Preferred Qualifications Experience establishing software quality and compliance processes in early-stage medical device organizations. Background supporting Class II or Class III medical products. Experience with capital equipment, surgical, interventional, imaging, or therapeutic medical technologies. Technical expertise in Python, C, and/or C++. Experience with real‑time, embedded, or hardware-integrated software systems. Why Join Us Help shape innovative healthcare technology that can improve patient outcomes. Lead software strategy for next‑generation clinical applications. Work alongside talented multidisciplinary teams across engineering, clinical, and regulatory functions. Build and grow a software organization from an early stage. Make a direct impact on products moving from development into commercialization. AI Software Lead - Capital Equipment Twin Cities, MN About the Opportunity An innovative medical technology company is seeking an AI Software Engineer to lead software development and regulatory compliance efforts for the expansion of a novel therapeutic platform. This role combines software engineering leadership, IEC 62304 documentation ownership, and program execution. The successful candidate will help transition early-stage software systems through development, verification, validation, and commercialization while working closely with multidisciplinary engineering, quality, and regulatory teams. As the initial hire for the software team, this role offers the opportunity to build and lead a software engineering team as the program matures and scales. This is a great chance for senior engineers and managers to work with a passionate group and build upon commercial success within a fast-paced, cutting-edge environment. What You'll Do Software Quality & Regulatory Compliance Lead software compliance activities in accordance with IEC 62304 and related medical device regulations. Conduct software gap assessments and establish software safety classifications. Develop and maintain key software lifecycle documentation, including: Software Development Plans Software Requirements Specifications Software Architecture Documentation Traceability matrices Design and risk management documentation Partner with Quality and Regulatory Affairs teams to support global regulatory submissions. Risk Management, Verification & Validation Own software risk management activities aligned with ISO 14971 and IEC 62304. Create and maintain software verification and validation strategies and plans. Lead software testing efforts across unit, integration, and system levels. Manage defect tracking, regression testing, and release readiness activities. Collaborate with human factors and safety teams to identify and mitigate software-related risks. Program & Project Leadership Drive software project planning, scheduling, and milestone execution. Identify program risks, dependencies, and resource needs.Communicate progress and project status to cross-functional stakeholders and leadership. Oversee software contractors and external development partners when applicable. Team Development & Technical Leadership Help define and build a high-performing software engineering organization. Participate in recruiting, onboarding, and mentoring software engineers. Establish scalable development processes and engineering best practices. Partner with technical teams to translate clinical and system requirements into software specifications. Provide technical guidance on architecture, implementation, and compliance strategy. Required Qualifications Bachelor's or Master's degree in Software Engineering, Computer Science, Electrical Engineering, or a related discipline. 10+ years of software development experience. 5+ years of experience developing software for regulated medical devices. Hands‑on experience with IEC 62304 software lifecycle processes and documentation. Strong understanding of ISO 14971 risk management principles. Experience leading software verification and validation activities. Familiarity with modern software development tools, version control systems, DevOps practices, and requirements/risk management platforms. Demonstrated project leadership experience in complex technical environments.Experience mentoring engineers or leading technical teams. Excellent written communication skills and ability to produce audit- and regulatory‑ready documentation. Preferred Qualifications Experience establishing software quality and compliance processes in early-stage medical device organizations. Background supporting Class II or Class III medical products. Experience with capital equipment, surgical, interventional, imaging, or therapeutic medical technologies. Technical expertise in Python, C, and/or C++. Experience with real‑time, embedded, or hardware-integrated software systems. Why Join Us Help shape innovative healthcare technology that can improve patient outcomes. Lead software strategy for next‑generation clinical applications. Work alongside talented multidisciplinary teams across engineering, clinical, and regulatory functions. Build and grow a software organization from an early stage. Make a direct impact on products moving from development into commercialization. Desired Skills and Experience IEC 62304

AI/ML

Software Development Plan Software Architecture EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. #J-18808-Ljbffr Real