System Engineer

Title: System Engineer
Location: Onsite, Boston, MA
Type: Contract to Hire
Hours: Standard business hours
Overview: Join a growing U.S. biotechnology organization supporting a federal initiative in next-generation RNA medicine manufacturing. Working alongside the Lead Systems Engineer, this role will own defined subsystems with a focus on requirements, interfaces, verification, traceability, risk management, and integration readiness across complex electromechanical and biotechnology platforms.

Responsibilities:

• Own requirements capture, development, and management for an assigned group of subsystems.
• Develop and maintain Interface Control Documents (ICDs), ensuring they remain current as system designs and requirements evolve.
• Develop verification plans and maintain requirements-to-evidence traceability throughout the development lifecycle.
• Facilitate FMEA activities and maintain an assigned portion of the programs risk, assumption, and tradeoff register.
• Support development of the interface specification between the manufacturing and analytics systems.
• Contribute to system-level size, weight, and power assessments.
• Own an assigned portion of the integration readiness record and execute verification activities for assigned subsystems during the build and integration phases.
• Support subsystem and system-level integration, troubleshooting, testing, and demonstration activities.
• Apply engineering design skills within a SolidWorks environment and collaborate with design engineering teams.
• Support control-system design and PLC programming as required for assigned subsystems.
• Develop, review, and maintain Process & Instrumentation Diagrams (P&IDs).
• Work closely with the Lead Systems Engineer and multidisciplinary technical teams to identify and resolve interface, integration, and verification issues.
• Maintain accurate requirements and traceability documentation throughout the program rather than recreating documentation ahead of formal design reviews.

Requirements:

• BS or MS in Mechanical, Electrical, Mechatronic, Chemical, Biomedical Engineering, or a related engineering discipline.
• 5+ years of systems engineering experience supporting multidisciplinary electromechanical products, ideally complex instrument or automated platform development.
• Experience supporting at least one program through integration and successful demonstration, beyond the design-review stage.
• Strong experience with:
  • Requirements capture and management
  • Interface definition and control
  • Verification planning and execution
  • Requirements traceability and associated tools
  • FMEA and technical risk management
• Experience within a regulated hardware environment, such as medical devices, pharmaceutical process equipment, in-vitro diagnostics, or a comparable industry.
• Working knowledge of SolidWorks, control-system design, PLC programming, and P&IDs.
• Ability to maintain detailed requirements, interfaces, and traceability throughout a rapidly evolving development program.
• Comfortable operating as the second Systems Engineer while independently owning a defined technical scope.
• Excellent written and verbal communication skills.
• Ability to work effectively across international, multidisciplinary, and multi-organizational teams while meeting aggressive project deadlines.

Preferred Qualifications

• INCOSE training or certification.

• Experience with single-use or cartridge-based instruments.

• Experience with model-based systems engineering (MBSE).
• Previous experience supporting federally funded development programs.
• Biotechnology, biomanufacturing, or complex instrumentation experience involving the integration of hardware, controls, engineering, and biological processes.

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