Principal System Engineer (Remote)

Full Spectrum; United States; On-site; USD 150,000 - 205,000; Full time

Job summary

A leading medical technology company is seeking a Principal System Engineer. This role involves leading various projects, conducting safety risk analyses, and providing regulatory guidance. You will be pivotal in translating clinical needs into engineering solutions. The ideal candidate should have at least 8 years of experience, a relevant bachelor’s degree, and a strong understanding of design controls and agile methodologies. The salary ranges from $150,000 to $205,000, with bonus eligibility.

Qualifications

• Minimum of 8 years of relevant experience in Systems Engineering.
• Proven track record in medical device development, identifying project risks.
• Deep understanding of design controls and software lifecycle coaching.

Responsibilities

• Lead project execution aligning client needs with team tasks.
• Conduct safety risk analysis for software-driven medical devices.
• Oversee system and software verification approaches.

Skills

Leadership in medical device development

Technical knowledge of design controls

Scripting in Python or C/C++

Agile methodologies

Education

Bachelor’s degree in Software, Electrical, Biomedical, or Computer Engineering

Tools

IDEs for code inspection

Automated Scrum tools

Job description

Full Spectrum partners with leading companies in MedTech to develop cutting-edge software for medical devices. With projects focused on embedded systems, mobile apps, robotics, engineers at Full Spectrum love the challenge of working with clients on products that have a meaningful impact. Working across different client projects with a wide range of technologies, a career at Full Spectrum offers both technical and professional growth opportunities.

Principal System Engineer

At Full Spectrum, our Systems Engineering team is the core differentiator that sets us apart from standard medical device service companies. As a Principal System Engineer, you aren't just using a highly efficient and compliant process, you will be working with Full Spectrum clients to improve their process and provide life-saving technology in a more repeatable manor. You will lead diverse projects, translating complex clinical needs into robust, secure, and compliant engineering realities.

Strategic Leadership & Client Impact

• Lead & Delegate: Manage project execution by aligning client needs with team tasks and deliverables.
• Consult & Partner: Collaborate with Regulatory Affairs partners to define system intent, launch strategies, and regulatory pathways.
• Mentor & Coach: Provide real-time guidance, training, and problem-solving for engineers, particularly within the Software Test and documentation realms.
• Process Innovation: Consult with Test Process owners to refine methodologies while minimizing audit exposure.

Technical Architecture & Risk Management

• Safety Risk Analysis: Lead planning for complex software-driven medical devices, perform top-down hazard and harm assessment working with Full Spectrum clients’ clinical tam or medical director, performing bottom-up failure analysis (FMEA) and identifying potential risk to safety.
• Cybersecurity Strategy: Drive the process for threat model analysis, cyber risk assessments, vulnerability analysis, and incident reporting to ensure full FDA compliance.
• Lifecycle Risk: Apply practical risk management throughout the entire product lifecycle, utilizing strong familiarity with both design and process risk models from ISO 14971.
• Requirements Mastery: Develop and implement requirement schemas and hierarchies using industry-standard RM tools, ensuring flawless allocation and traceability.

V&V Strategy & Regulatory Mastery

• V&V Leadership: Oversee system and software V&V approaches, including test planning, design, and the creation of comprehensive test cases.
• Testing Strategy: Implement lifecycle-based testing (IEC 62304), covering everything from unit testing to system-level GUI testing.
• System Verification: Define and oversee system integration over development, define performance characterization tests and test requirements and test methods, coordinate and plan testing of the system at meaningful milestones to mitigate project risk and to meet defined performance requirements.

Standard Compliance

• Software & Risk: IEC 62304, ISO 14971, TIR-32, TIR-45, TIR 80001, and IEC 81001-5-1.
• Hardware & Safety: IEC 60601-1, IEC 60601-1-8.
• Quality & Process: 21 CFR Part 820, IEC 13485, and ISPE GAMP-5.
• Usability: IEC 62366 and basic usability design principles.

Qualifications

• Education: Bachelor’s degree in Software, Electrical, Biomedical, or Computer Engineering (or a related science discipline).
• Experience: Minimum of 8 years of relevant experience in Systems Engineering.
• Leadership: Proven track record in medical device development, identifying project risks, and communicating clearly with stakeholders.
• Technical Knowledge: Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes for continuous integration.

Desirable Skills: Nice to Have

• Technical Proficiencies: Scripting in Python or C/C++, code inspection, and Object-Oriented Programming.
• Emerging Tech: Experience with Machine Learning systems, algorithm management, and real-time/embedded programming.
• Modern Methodology: Familiarity with Agile, version control, and automating compliant CI/CD pipelines.

The base salary for this position is $150,000 to $205,000 annually, and the role is bonus eligible. The final salary offer is determined by factors such as experience, location, skills, education, and market conditions.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.