Senior Principal Software Engineer — Medical Device Compliance

Logisolve; Plymouth (MN); On-site; USD 180,000 - 230,000; Full time

Job summary

Logisolve is seeking a senior software leader to own the software lifecycle for regulated medical device software. You will drive SDP, SRS, architecture, DFMEA, and traceability, partnering with Regulatory Affairs and Quality to meet global submissions.

You will shape architecture, select tech stacks, mentor engineers, and lead verification/validation across complex systems while aligning with cross-functional teams and cybersecurity goals.

Qualifications

• Bachelor's degree in software engineering, CS, or related field.
• 10+ years of software development experience, including 5+ years for regulated medical devices.
• Deep expertise in IEC 62304 and medical device software lifecycle processes.
• Hands-on experience authoring SDP, SRS, software architecture descriptions, DFMEA, traceability, and verification docs.
• Direct experience with software risk management per ISO 14971.
• Proven leadership of verification and validation across complex systems.
• Strong software architecture and system design capabilities.
• Experience integrating AI tools into DevOps, Git, and Relyence or similar.
• Project leadership managing technical deliverables in cross-functional environments.
• Excellent written and verbal communication for regulatory-quality documentation.

Responsibilities

• Define software safety classifications and perform gap analyses per IEC 62304.
• Own SDP, establishing development methodology, CM, version control, reviews, and releases.
• Create SRS, SAD, and software-level DFMEA per design controls.
• Maintain requirements-to-implementation traceability across the lifecycle.
• Collaborate with Regulatory Affairs and Quality for global submissions.
• Serve as SME for software lifecycle compliance and design control activities.
• Define software architecture and roadmaps for future indications and product evolution.
• Lead critical technical decisions on design, scalability, and cybersecurity.
• Translate clinical/system requirements into software specs with cross-functional teams.
• Define tech stacks and frameworks for treatment planning and therapy delivery software.

Skills

Software leadership

Regulatory expertise

Lifecycle processes

Communication skills

Education

Bachelor's degree in software engineering, CS, or Electrical Engineering

Tools

Relyence

Git

Regulatory document tooling

Job description

Logisolve is seeking a senior software leader to own the software lifecycle for regulated medical device software. You will drive SDP, SRS, architecture, DFMEA, and traceability, partnering with Regulatory Affairs and Quality to meet global submissions.

You will shape architecture, select tech stacks, mentor engineers, and lead verification/validation across complex systems while aligning with cross-functional teams and cybersecurity goals.