System Engineer
Boston, Massachusetts
Experience: 5
Category: Scientific & Clinical
Contractor Work Model: Onsite
Brand: System One
Job ID: 380852
Date Posted: 09/24/2026
Shortcut: http://jobs.systemone.com/XLbOxC
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.
-
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
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