System Engineer

System One; Cambridge (MA); On-site; USD 9,919,000 - 10,745,000; Part time

Job summary

System One is seeking a System Engineer to join onsite in Boston, MA, under a Contract to Hire arrangement. The role focuses on defining subsystems, interfaces, verification, traceability, and risk management across electromechanical and biotechnology platforms.

You will own defined technical scope alongside the Lead Systems Engineer. Responsibilities include creating ICDs, verification planning, and contributing to system integration readiness.

Qualifications

• BS or MS in Mechanical, Electrical, Mechatronic, Chemical, Biomedical Engineering, or related discipline.

Responsibilities

• Own requirements capture and management for subsystems.
• Develop and maintain ICDs as designs evolve.
• Develop verification plans and maintain traceability.
• Support risk management, FMEA, and risk registers.
• Define interface specs between manufacturing and analytics systems.
• Contribute to system-level size, weight, and power assessments.
• Own verification activities during build and integration phases.
• Support subsystem and system-level integration, testing, and demonstrations.
• Apply engineering in SolidWorks and collaborate with design teams.
• Develop P&IDs and review documentation throughout program.
• Work with multidisciplinary teams to resolve interface and verification issues.
• Maintain detailed requirements and traceability throughout development.

Skills

Requirements capture

Interface definition

Verification planning

Traceability

FMEA & risk mgmt

Systems engineering

Communication

Cross-functional teamwork

Regulated hardware

MBSE awareness

Education

BS or MS in Engineering

Tools

SolidWorks

P&IDs

Control-system design

PLC programming

Interface control docs (ICDs)

Job description

Title: System Engineer
Location: Onsite, Boston, MA
Type: Contract to Hire
Hourly rate: $73.08
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 program’s 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.

#M3
#LI-DS2
Ref: #558-Scientific