Principal Software Engineer - Compliance Lead

Principal Software Engineer - Compliance Lead

Twin Cities, MN

An innovative medical technology company is seeking a Principal Software Engineer focused on expanding a breakthrough, non-invasive therapeutic technology into new clinical applications. This team functions as a startup in the broader established organization currently in a rapid prototyping phase.

Throughout prototyping, the software architect utilized AI code generation techniques with manual review and editing to develop a functional codebase for their current prototype. In this role, you would work closely with the architect to assess the existing code and develop a strategy towards FDA software compliance, including ownership of the relevant documentation and leading verification/validation activities.

This is a hands on position that may allow for technical leadership as the team grows to support clinical trials and commercialization. This is a great chance for senior engineers to work with a passionate group and build upon previous commercial success within a fast-paced, cutting-edge environment targeting new indications.

• Assess software systems against IEC 62304 requirements and define software safety classifications.
• Perform gap analyses and establish compliant software development processes.
• Author and maintain key software lifecycle documentation, including:
• Software Development Plans (SDP)
• Software Requirements Specifications (SRS)
• Software Architecture Descriptions (SAD)
• Software-level DFMEA documentation
• Develop and maintain requirements traceability throughout the software lifecycle.
• Partner with Quality and Regulatory Affairs teams to ensure documentation supports global regulatory submissions.
• Serve as the subject matter expert for software lifecycle compliance and design controls.

• Lead software risk management activities in accordance with ISO 14971 and IEC 62304.
• Define and maintain software verification and validation strategies.
• Establish traceability between requirements, testing activities, and objective evidence.
• Review software test strategies covering unit, integration, and system-level verification.
• Oversee defect management, regression testing, and software release qualification activities.
• Collaborate with Human Factors and Safety teams to identify and mitigate software-related risks.

• Define software architecture and technical roadmaps supporting future product and clinical expansions.
• Drive critical decisions related to scalability, maintainability, cybersecurity, and system design.
• Collaborate with systems, clinical, product development, and scientific teams to translate requirements into software solutions.
• Evaluate development frameworks, technology stacks, and emerging tools that enhance product quality and engineering efficiency.

• Own software development plans, milestones, and deliverables aligned with broader program objectives.
• Identify technical risks, dependencies, and mitigation strategies.
• Coordinate external software development partners and vendors while ensuring compliance with design control requirements.
• Communicate progress, risks, and recommendations to leadership and executive stakeholders.

• Bachelor's degree in Software Engineering, Computer Science, Electrical Engineering, or a related field.
• 10+ years of software development experience, including at least 5 years in regulated medical device environments.
• Deep expertise with IEC 62304 and medical device software development lifecycle processes.
• Hands-on experience developing and maintaining software compliance documentation.
• Direct experience with software risk management under ISO 14971.
• Proven leadership of software verification and validation activities.
• Strong software architecture and systems design experience.
• Familiarity with integrating modern AI-enabled development tools into engineering workflows.
• Experience leading technical deliverables within complex, cross-functional organizations.
• Excellent written and verbal communication skills, including the…