Lead System Engineer

Title: Lead System Engineer
Location: Onsite, Boston, MA
Type: Contract to Hire
Hourly rate: $76.92 an hour
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 Solid Works environment
• Control systems design and PLC programming skills
• Working knowledge on developing and maintaining process & instrumentation diagrams (P&)

• 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.