Principal Software Engineer - Compliance Lead

About the role

Principal Software Engineer - Compliance Lead

Twin Cities, MN

About the Opportunity

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.

What You'll Do

Software Compliance & Lifecycle Management

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.

Risk Management, Verification & Validation

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.

Technical Leadership & Architecture

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.

Program & Project Leadership

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.

Required 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.

Preferred Qualifications

Experience establishing software processes from early-stage product development through commercialization.

Background in capital equipment, image-guided therapies, surgical technologies, or interventional medical systems.

Experience with Python, C, and/or C++ in regulated environments.

Familiarity with real-time and embedded software architectures.

Experience supporting FDA, EU MDR, or other global medical device regulatory submissions.

Previous experience as a Principal Engineer, Technical Lead, or Software Architect on multidisciplinary product development programs.

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.

Make a direct impact on products moving from development into commercialization.

Desired Skills and Experience

IEC 62304, AI/ML, Software Development Plan, Software Architecture, V&V Planning, Compliance

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.

To find out more about Real, please visit www.realstaffing.com