Senior Systems Engineering Lead — Biotech Manufacturing

System One, Inc.; Boston (MA); On-site; USD 87,000 - 125,000; Full time

Job summary

System One, Inc. is seeking a Lead System Engineer for an onsite Boston, MA contract-to-hire role.

The candidate will oversee the entire system, including architecture, requirements, interfaces, integration, verification, and validation of a complex manufacturing platform in a regulated environment. This leadership role demands hands-on engineering in PLC programming, SolidWorks, and process diagrams, plus strong communication across multi-disciplinary teams and external partners to deliver a

Qualifications

• BS or MS in listed engineering fields; PhD desirable.
• 7+ years in systems engineering on complex electromechanical products.
• Experience in regulated hardware domains (medical or pharma).

Responsibilities

• Define system requirements covering modalities and manufacturing attributes.
• Create the system architecture document with initial BOM.
• Define integration interface specs, data schemas, and handoff timing.
• Develop verification and validation strategy and risk registers.
• Lead full-system functional verification and fault-tolerance campaigns.
• Possess skills in SolidWorks and PLC programming; work with P&ID.

Skills

Systems engineering leadership

Requirements management

Verbal and written communication

Cross-disciplinary collaboration

Education

Bachelor's or Master's in mechanical, electrical, mechatronic, aerospace, chemical or biomedical engineering

PhD in related field desirable

Tools

SolidWorks

PLC programming

P&ID development

Interface control documents

Job description

System One, Inc. is seeking a Lead System Engineer for an onsite Boston, MA contract-to-hire role.

The candidate will oversee the entire system, including architecture, requirements, interfaces, integration, verification, and validation of a complex manufacturing platform in a regulated environment. This leadership role demands hands-on engineering in PLC programming, SolidWorks, and process diagrams, plus strong communication across multi-disciplinary teams and external partners to deliver a