Biotech Systems Engineer – Integration & Verification

System One, Inc.; Boston (MA); On-site; USD 83,000 - 118,000; Full time

Job summary

System One, Inc. seeks a Systems Engineer in Boston to own subsystems, manage requirements, interfaces, and verification across electromechanical and biotech platforms. You will develop ICDs, drive risk management, and coordinate with cross-functional teams, including analytics and manufacturing interfaces.

The role requires 5+ years in systems engineering, experience with regulated hardware, and SolidWorks-based design support. This is a contract-to-hire position with standard hours onsite.

Qualifications

• 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.
• Experience supporting at least one program through integration and demonstration beyond the design-review stage.
• Strong experience with requirements capture and management.
• Interface definition and control experience.
• Verification planning and execution.
• Requirements traceability and related tools.
• FMEA and technical risk management.
• Experience within regulated hardware environments (medical devices, pharmaceutical process equipment, in-vitro diagnostics, or similar).
• 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 across international, multidisciplinary teams while meeting deadlines.

Responsibilities

• Own requirements capture, development, and management for an assigned group of subsystems.
• Develop and maintain Interface Control Documents (ICDs) and keep them current as designs evolve.
• Develop verification plans and maintain requirements-to-evidence traceability throughout the lifecycle.
• Facilitate FMEA activities and manage a portion of the program's risk and tradeoff register.
• Support development of the interface specification between 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.
• Support subsystem and system-level integration, testing, and demonstrations.
• Apply engineering design skills within SolidWorks and collaborate with design teams.
• Support control-system design and PLC programming for assigned subsystems.
• Develop, review, and maintain P&IDs.
• Work with the Lead Systems Engineer and multidisciplinary teams to resolve interface/verification issues.
• Maintain accurate requirements and traceability documentation throughout the program.

Skills

Requirements capture

Interface control

Verification planning

Traceability tools

FMEA & risk management

Regulated hardware experience

SolidWorks

Control-system design

PLC programming

P&IDs

Documentation & communication

Cross-functional collaboration

Education

Bachelor's or Master's in Mechanical, Electrical, Mechatronic, Chemical, Biomedical Engineering, or related field

Job description

System One, Inc. seeks a Systems Engineer in Boston to own subsystems, manage requirements, interfaces, and verification across electromechanical and biotech platforms. You will develop ICDs, drive risk management, and coordinate with cross-functional teams, including analytics and manufacturing interfaces.

The role requires 5+ years in systems engineering, experience with regulated hardware, and SolidWorks-based design support. This is a contract-to-hire position with standard hours onsite.