Lead System Engineer

Title: Lead System Engineer
Location: Onsite, Boston, MA
Type: Contract to Hire
Hours: Standard business hours
Overview: Join a growing U.S. biotechnology organization focused on next-generation RNA medicine manufacturing. The Systems Engineering Lead will oversee the entire system, managing architecture, requirements, interfaces, integration, verification, and validation of a complex manufacturing platform. This role involves decomposing the platform into subsystems, defining interfaces, and integrating an analytics system developed with an external partner, requiring strong systems engineering leadership and hands-on engineering expertise in a regulated environment.

Responsibilities:

• The system requirements document covering several drug substance modalities and the physical attributes and specification of the manufacturing system to be developed
• The system architecture document with initial bill of materials.
• The integration interface specification defining sampling points, data and metadata schemas, handoff timing and control-interaction boundaries.
• The verification and validation strategy, the system-level risk register, and the integration readiness record that gates the start of system integration.
• Full-system functional verification and the off-nominal fault-tolerance and recovery campaign.
• Some engineering design skills and the ability to work in a SolidWorks environment
• Control systems design and PLC programming skills
• Working knowledge on developing and maintaining process & instrumentation diagrams (P&ID)

Requirements:

• BS or MS in mechanical, electrical, mechatronic, aerospace, chemical or biomedical engineering. PhD in related field is desirable.
• At least 7 or more years in systems engineering on complex multi-disciplinary electromechanical products, including at least five as systems lead on a programme that was actually integrated and demonstrated.
• Fluency in requirements management, architecture decomposition, interface control, trade studies, FMEA, verification planning and traceability.
• Direct experience in a regulated hardware domain — medical device design controls, pharmaceutical process equipment, in-vitro diagnostics or comparable.
• The discipline to write verifiable requirements, refuse unverifiable ones, and keep traceability current rather than reconstructing it before a review.
• Excellent verbal and written communication skills
• Ability to work in international, multi-disciplinary and multi-organisational teams and tight deadlines
• Nice to have: INCOSE CSEP. Single-use or cartridge-based instruments. Aseptic or isolator equipment. Model-based systems engineering.

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Ref: #558-Scientific