The U.S. Food and Drug Administration (FDA) published a September 2026 draft guidance on premarket submissions for certain robotically assisted surgical devices (RASDs). It discusses nonclinical testing, clinical data, and labeling. The document is explicitly a draft, is not for implementation, and contains nonbinding recommendations; comments are due November 24, 2026. For employers, its practical value is as a role-scoping checklist: clarify who will own the technical evidence and cross-functional handoffs for a device program. This is a hiring-planning lens, not regulatory advice or evidence that hiring demand is rising.
Start with the device and submission scope
Before writing a job description, define the system, intended use, development stage, and the submission strategy established by your regulatory team. FDA describes the RASDs covered by the draft as teleoperated, software-controlled systems used under the direct control or supervision of qualified practitioners. The guidance says it does not address remotely teleoperated RASDs or autonomous robots that perform significant aspects of procedures independently, although some recommendations may still be relevant to those devices. The boundary matters: a role built around the wrong product assumptions can blur ownership before the search begins.
Read the FDA draft guidance and its scope notes with your regulatory and engineering leaders. Treat it as a source for questions to resolve, not a checklist that automatically applies to every product.
Translate the work into role outcomes
The draft covers several technical and evidence areas. They can help an employer identify the work to be owned, while leaving the eventual title and team structure to the device program.
- System performance and verification: The guidance discusses areas such as system-level and nonclinical performance testing, controls, motion characteristics, visualization, reliability, and safety features. Decide which deliverables a systems or verification engineer would own, and how the work connects to design inputs, risk controls, and test evidence.
- Software, cybersecurity, and connectivity: FDA addresses software verification and validation, cybersecurity, and wireless technology. Specify whether the hire will lead software evidence, integrate it with system testing, coordinate cybersecurity work, or partner with specialists in these areas.
- Human factors and training: FDA recommends that human-factors evaluations begin early and continue iteratively. Its draft also discusses training for users who interact with the device. Define how usability, user groups, operating-room workflows, training, and labeling will be coordinated.
- Clinical and regulatory evidence: FDA says clinical data are often needed for new RASDs; for modifications to previously authorized devices, clinical data may be requested in particular circumstances. The role brief should reflect the actual development and submission plan, rather than assume the same clinical workload for every device.
Answer five questions before opening the search
- Which device, intended use, users, and development stage does this role support?
- What specific deliverables will the person own in the first six to twelve months?
- Where are the handoffs among systems engineering, software, cybersecurity, human factors, clinical, quality, and regulatory teams?
- Which work is performed internally, and which is handled by consultants, test labs, clinical partners, or other vendors?
- What experience is essential on day one, and what can be learned after joining?
These answers turn a broad request for “robotics experience” into a more useful brief. For example, an employer may need a systems engineer who can coordinate verification across subassemblies, a software quality leader who can connect software evidence to system testing, or a human-factors specialist who can work across design and validation. Those are possible role shapes, not FDA-mandated positions.
Interview for the work, not just the title
Ask candidates to describe a comparable project without sharing confidential information. What part of the system did they own? How did they connect requirements, risk analysis, verification, and user needs? Which teams or external partners were involved? How did they handle a changed design, a test result that missed its acceptance criteria, or a gap between the intended use and the available evidence?
Questions like these help distinguish direct experience from familiarity with terminology. They also let the hiring team evaluate whether a candidate’s depth matches the role’s center of gravity, instead of expecting one person to cover every technical and regulatory discipline.
Keep the evidence and the role current
The November 24 comment date creates a near-term reason for device teams to review the draft with their regulatory and engineering leaders. Any hiring plan should remain tied to the company’s actual product, intended use, and submission strategy as those decisions evolve. The draft is not a final rule, and the FDA says guidance recommendations are nonbinding.
For adjacent hiring needs in production engineering, process transfer, and manufacturing support, see our guide to scoping a medical device manufacturing engineer role and our medical-device manufacturing and engineering recruiting practice. HealthStaffingGroup supports employers with permanent medical-device and MedTech searches. Request an employer consultation to discuss a role brief.
Primary source
Robotically-Assisted Surgical Devices — Premarket Submissions: Draft Guidance for Industry and FDA Staff, FDA, September 2026. FDA-2026-N-9505.
