Staff Systems Engineer - Robotics | Medical Devices | Systems Architecture

Job Description

Job Description

About the Opportunity

A venture-backed robotics company developing an advanced, AI-enabled medical technology platform is seeking a Staff Systems Engineer to own systems engineering and design assurance for a complex robotic medical device.

This is a highly influential, hands‑on role for a seasoned systems engineer who can operate at the intersection of system architecture, hardware, software, controls, risk management, verification and validation, and FDA design controls
.

You will own the architecture and requirements that flow through the system, the interfaces between subsystems, the risk management framework, the V&V program, traceability, and the Design History File. More importantly, you will help establish how the engineering organization builds, bringing risk‑based thinking into design decisions from the beginning so that safety, verifiability, and standards conformance are engineered into the product rather than discovered late in development.

This is not a downstream quality or documentation role. You will work directly alongside mechanical, electrical, software, controls, clinical, quality, and regulatory stakeholders, guiding architecture and design decisions while helping advance the platform toward regulatory submission and commercialization.

The position is on‑site in the Columbus, Ohio area and reports directly to senior engineering leadership.

What You’ll Do

• Establish and lead a risk-based systems engineering process
  , driving identified hazards to documented mitigation before design freezes so issues surface during engineering and design review rather than late in V&V or audit.
• Translate user and clinical needs into verifiable engineering specifications with clearly defined acceptance criteria, including performance targets, power budgets, dimensional and weight constraints, applied-force limits, and safety requirements.
• Own the system architecture for a complex robotic medical platform spanning mechanical systems, electronics, embedded systems, firmware, software, controls, sensing, and third‑party medical equipment.
• Define and manage subsystem interfaces
  , authoring interface control documentation for data, power, electrical, software, and mechanical boundaries to reduce integration risk and prevent cross‑domain failures.
• Build and maintain end‑to‑end requirements traceability
  , linking user needs to system requirements, design outputs, risk controls, and verification evidence with complete coverage and no orphan requirements.
• Lead risk management activities under ISO 14971
  , including hazard analysis, FMEAs, risk‑control definition, mitigation traceability, residual‑risk evaluation, and verification of risk‑control effectiveness.
• Own the verification and validation program
  , including V&V strategy, planning, protocol development, execution oversight, reporting, and traceable verification of design outputs against design inputs.
• Own and mature the Design History File and design‑control process
  , leading phase‑gate design reviews, documenting action closure, and helping transition critical systems and design‑assurance capabilities from external support into the internal organization.
• Establish and verify conformance to applicable medical‑device standards
  , including the IEC 60601 family, IEC 62304, IEC 62366, ISO 13485, and ISO 14971.
• Lead system integration and bring‑up
  , working hands‑on with engineering teams to root‑cause failures that cross mechanical, electrical, software, firmware, sensing, and controls boundaries.
• Establish configuration management, requirements management, design review, and test‑management infrastructure appropriate for a growing regulated robotics organization.
• Partner closely with regulatory strategy to deliver a complete, submission‑ready design controls and V&V evidence package supporting a 510(k) pathway.
• Help anchor the systems engineering discipline as the company scales
  , establishing practical methods, tools, decision frameworks, and engineering rigor without creating unnecessary bureaucracy.

About You

• Bachelor’s degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Robotics, or a related technical discipline.…