Principal Software Engineer & Compliance Lead (MedTech)

Real; Minneapolis (MN); On-site; USD 180,000 - 240,000; Full time

Job summary

Real is seeking a Principal Software Engineer focused on Compliance Lead to guide FDA software compliance strategy in a fast-paced clinical expansion project. You will own software lifecycle documentation, lead verification and validation activities, and partner with QA and Regulatory teams for global submissions.

The role combines hands-on development with technical leadership, shaping architecture, roadmaps, and design controls to ensure scalable, safe software for new clinical applications.

Qualifications

• 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 ability to create regulatory-quality documentation and influence technical decisions.

Responsibilities

• 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 SDP, SRS, SAD, and DFMEA.
• Develop and maintain requirements traceability throughout the software lifecycle.
• Partner with Quality and Regulatory Affairs teams to support 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.
• 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.

Skills

Software architecture

Regulatory compliance

Leadership

V&V planning

Education

Bachelor's degree in Software Engineering/CS/EE

Tools

Python

C

C++

Job description

Real is seeking a Principal Software Engineer focused on Compliance Lead to guide FDA software compliance strategy in a fast-paced clinical expansion project. You will own software lifecycle documentation, lead verification and validation activities, and partner with QA and Regulatory teams for global submissions.

The role combines hands-on development with technical leadership, shaping architecture, roadmaps, and design controls to ensure scalable, safe software for new clinical applications.