Principal System Engineer (Remote)

6 hours, 4 minutes ago
Full-time
Lead
DevOps and Infrastructure
Full Spectrum

Full Spectrum

Full Spectrum specializes in the efficient and reliable market introduction of medical devices and life sciences instruments, leveraging extensive experience in organizing and transporting data from regulated devices.

Internet Software & Services
51-250
Founded 1982

Description

  • Serve as the primary technical interface for clients on mission-critical medical device projects.
  • Lead project execution by aligning client needs with team tasks and deliverables.
  • Collaborate with Regulatory Affairs partners on system intent, launch strategies, and regulatory pathways.
  • Provide real-time guidance, training, and problem-solving for engineers, especially in software test and documentation.
  • Refine test processes and methodologies with test process owners while minimizing audit exposure.
  • Lead safety and security by design efforts for complex systems from the earliest stages of development.
  • Perform safety risk analysis, including hazard and harm assessment and FMEA.
  • Drive cybersecurity activities including threat modeling, cyber risk assessments, vulnerability analysis, and incident reporting.
  • Develop requirement schemas and hierarchies with traceability using industry-standard requirements management tools.
  • Define and oversee V&V strategies, including test planning, test design, and comprehensive test case creation.

Requirements

  • Bachelor’s degree in Software, Electrical, Biomedical, or Computer Engineering, or a related science discipline.
  • Minimum of 8 years of relevant Systems Engineering experience.
  • Proven track record in medical device development, project risk identification, and stakeholder communication.
  • Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes for continuous integration.
  • Strong familiarity with design and process risk models, including ISO 14971.
  • Subject matter knowledge of IEC 62304, ISO 14971, TIR-32, TIR-45, TIR 80001, IEC 81001-5-1, IEC 60601-1, IEC 60601-1-8, 21 CFR Part 820, IEC 13485, ISPE GAMP-5, and IEC 62366.
  • Experience with scripting in Python or C/C++, code inspection, and object-oriented programming is preferred.
  • Experience with machine learning systems, algorithm management, and real-time/embedded programming is preferred.
  • Familiarity with Agile, version control, and automating compliant CI/CD pipelines is preferred.

Benefits

  • Remote work opportunity.
  • Full-time position.
  • Base salary of $150,000 to $205,000 annually.
  • Bonus eligibility.
  • Opportunity to work on meaningful medical device technology with leading MedTech companies.
  • Opportunities for technical and professional growth across diverse client projects.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Lead IT Systems Engineer

Klaviyo 1K-5K IT Services

Klaviyo is hiring a Lead IT Systems Engineer to lead enterprise SaaS systems administration, automation, and integrations within its global corporate IT organization.

Agile Ansible AWS Azure Bash DNS EC2 GCP LLM OpenID Connect PowerShell Python REST API Terraform
4 hours, 52 minutes ago

Senior Office 365 Infrastructure & Security Operations Engineer

OSINT Combine 11-50 Diversified Consumer Services

A Senior Office 365 Infrastructure & Security Operations Engineer at an intelligence software company will support and scale the cloud, internal IT, and security operations behind mission-critical platforms used by government and security customers.

AWS Bash CI/CD Linux macOS PowerShell Python
5 hours, 19 minutes ago

Distributed Systems Engineer

MLabs 11-50 Internet Software & Services

Remote full-time engineering role building next-generation real-time market infrastructure for an innovative client, focused on turning ambiguous problems into production-grade systems that shape how value is discovered, priced, and distributed.

Rust
5 hours, 49 minutes ago

Senior Systems Engineer

ActiveCampaign 251-1K Internet Software & Services

ActiveCampaign is seeking a Senior Systems Engineer to lead the automation, security, and modernization of corporate IT infrastructure for a fast-growing, AI-first company.

Ansible AWS Azure CI/CD Docker GCP GitOps Kubernetes Linux Python Terraform Unix
6 hours, 4 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers