Full Spectrum Search Group

Full Spectrum Search Group

Principal System Engineer

Westborough, MA · Principal

Sponsorship not specified$150k-$205kDetected 141 days ago
PythonC++CI/CDMachine LearningProduct ManagementAgileEmbedded SystemsSystems EngineeringRoboticsFDA RegulatoryMedical DevicesLeadershipProblem SolvingMentoringRegulatory Affairs

About the role

  • 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.
  • V&V Strategy & Regulatory Mastery: You will define the path to market by establishing rigorous V&V strategies within an iterative development environment.

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.
  • You will be responsible for how teams address "Safety and Security by Design" of complex systems, ensuring protective measures are embedded from the earliest stages of development.
  • Drive the process for threat model analysis, cyber risk assessments, vulnerability analysis, and incident reporting to ensure full FDA compliance.
  • Oversee system and software V&V approaches, including test planning, design, and the creation of comprehensive test cases.
  • Implement lifecycle-based testing (IEC 62304), covering everything from unit testing to system-level GUI testing.
  • IEC 62366 and basic usability design principles.
  • Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes for continuous integration.
  • Consult & Partner: Collaborate with Regulatory Affairs partners to define system intent, launch strategies, and regulatory pathways.
  • Technical Architecture & Risk Management: You will be responsible for how teams address "Safety and Security by Design" of complex systems, ensuring protective measures are embedded from the earliest stages of development.

Requirements

  • Minimum of 8 years of relevant experience in Systems Engineering.
  • Bachelor's degree in Software, Electrical, Biomedical, or Computer Engineering (or a related science discipline).
  • Education: Bachelor's degree in Software, Electrical, Biomedical, or Computer Engineering (or a related science discipline).
  • 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.
  • The base salary for this position is $150,000 to $205,000 annually, and the role is bonus eligible.

Nice to have

  • Desirable Skills: (Nice to Have): Technical Proficiencies: Scripting in Python or C/C++, code inspection, and Object-Oriented Programming.

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 final salary offer is determined by factors such as experience, location, skills, education, and market conditions. **

Compensation

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