Title: Lead System EngineerLocation: Onsite, Boston, MAType: Contract to HireHours: Standard business hoursOverview: 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.
#M3 #LI-MD2 Ref: #558-Scientific
