Full Spectrum Software-posted 3 months ago
Full-time • Senior
Westborough, MA
11-50 employees
Publishing Industries

This position requires knowledge and experience in driving Systems Engineering on multiple engineering projects. This Principal position requires direct customer interface and the leadership to manage a project and delegate tasks, based on agreed to client needs to other team members. This position requires in-depth knowledge of system engineering skills including: Safety Risk Analysis, Project and V&V Leadership, Requirements Management, Compliance Engineering, Software Testing strategy experience, and Cybersecurity process and compliance.

  • Drive Systems Engineering on multiple engineering projects.
  • Interface directly with customers and manage project tasks.
  • Perform Safety Risk Analysis for complex medical devices.
  • Lead project and V&V activities, including test planning and design.
  • Manage requirements development and implementation using management tools.
  • Ensure compliance with key Standards/FDA guidance for medical devices.
  • Develop software testing strategies and understand software lifecycle.
  • Support cybersecurity compliance and documentation.
  • Experience in Systems Engineering and safety analysis.
  • Leadership experience in medical device development.
  • Ability to define activities, identify project risks, and communicate effectively.
  • Familiarity with IEC 13485, ISO 14971, and FDA regulations.
  • Understanding of software risk processes and design risk models.
  • Solid background in Electrical engineering and familiarity with Mechanical engineering.
  • Minimum 4 years of Software development experience.
  • C/C++ expertise.
  • Experience with Machine Learning systems.
  • Real-Time & Embedded Programming experience.
  • Understanding of design controls and regulatory compliance.
  • Experience with technical documentation in a regulated industry.
  • Familiarity with Agile methodology & Version Control.
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