Principal Systems Engineer

Full Spectrum Software • Westborough, MA

149d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Publishing Industries
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees