Principal System Engineer

Full Spectrum partners with leading companies in MedTech to develop cutting-edge software for medical devices. The company offers opportunities for technical and professional growth through diverse projects involving embedded systems, mobile apps, and robotics.

Location: Not specified

Salary: $150,000–$205,000/yr, bonus eligible

Responsibilities

• Manage project execution by aligning client needs with team tasks and deliverables.
• Collaborate with Regulatory Affairs partners to define system intent, launch strategies, and regulatory pathways.
• Provide real-time guidance, training, and problem-solving for engineers, particularly within the Software Test and documentation realms.
• Consult with Test Process owners to refine methodologies while minimizing audit exposure.
• Lead planning for complex software-driven medical devices, perform hazard and harm assessments, and identify potential risks to safety.
• Drive cybersecurity strategies including threat model analysis, cyber risk assessments, vulnerability analysis, and incident reporting.
• Apply risk management throughout the product lifecycle using ISO 14971.
• Develop and implement requirement schemas and hierarchies using industry-standard RM tools.
• Establish V&V strategies within an iterative development environment.
• Oversee system and software V&V approaches, including test planning, design, and creation of test cases.
• Implement lifecycle-based testing covering unit to system-level testing.
• Act as a subject matter expert on standards and FDA guidance including IEC 62304, ISO 14971, IEC 60601-1, 21 CFR Part 820, IEC 13485, IEC 62366.
• Coordinate and plan testing at milestones to mitigate project risk.
• Define and oversee system integration, performance characterization tests, and test requirements.

Requirements

• Bachelor’s degree in Software, Electrical, Biomedical, or Computer Engineering (or a related science discipline).
• Minimum of 8 years of relevant experience in Systems Engineering.
• Proven track record in medical device development, risk identification, and stakeholder communication.
• Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes.

Benefits

• The base salary for this position is $150,000 to $205,000 annually, and the role is bonus eligible.

Additional Information

• The final salary offer is determined by factors such as experience, location, skills, education, and market conditions.
• Originally posted on Himalayas.