Qa Engineer_ Medical Device Contractual

CONTRACTUAL REMOTE

The candidate will work on an image-guided surgical navigation system used intraoperatively during Total Ankle Replacement (TAR). It is an offline, Linux-based application that integrates third-party camera SDKs, Restor3d-supplied registration/tracking algorithms, and an off-the-shelf AI segmentation model, and exchanges encrypted patient case files by USB. Understanding this regulatory frame is part of the role:

• FDA product code OLO Orthopedic Stereotaxic Instrument, Class II, 21 CFR 882.4560, cleared via the 510(k) pathway and subject to special controls. This Class II navigation pathway is what drives the required rigor.
• FDA product code LMD System, Digital Image Communications, Radiological, Class I, 21 CFR 892.2020 (generally 510(k)-exempt). Covers the image-communication elements of the system.
• Software safety classification — expected to be IEC 62304 Class C (intraoperative guidance affecting resection decisions); Restor3d assigns the final class.
• Quality system — software design controls under 21 CFR 820.30, now harmonized under FDA's Quality Management System Regulation (QMSR) incorporating ISO 13485:2016.

2. What this role is accountable for

• Establish and run the software design-control process for the project, consistent with 21 CFR 820.30 / QMSR / ISO 13485 and Restor3d's QMS.
• Own the IEC 62304 life-cycle documentation set: Software Development Plan, software requirements, architecture and detailed design, unit / integration / software-system verification, release, and maintenance planning — scaled to the assigned safety class.
• Plan and drive software verification & validation: author test protocols and reports, and establish requirement design code test traceability, with results traceable to a specific software version.
• Support Restor3d's ISO 14971 risk management: translate hazards into software risk controls, evidence their implementation and verification, and maintain the software contributions to the risk file.
• Manage SOUP and the SBOM (operating system, camera SDKs, open-source libraries, the COTS AI model): identification, version-pinning, justification, and known-anomaly assessment.
• Prepare software cybersecurity documentation (threat model, SBOM, security risk management) consistent with current FDA premarket cybersecurity expectations.
• Support human factors / usability engineering (IEC 62366-1 and FDA human-factors guidance) for the surgeon-facing workflow.
• Assemble the software documentation for the FDA 510(k) at the applicable Documentation Level, feeding Restor3d's submission and Design History File (DHF).
• Run design reviews, configuration management, and the problem / anomaly-resolution process (IEC 62304 •9).
• Act as the regulatory/quality interface between Capital Numbers engineering and Restor3d's RA/QA team.

3. Required qualifications & skills (must-have)

• 5+ years (senior: 8+) in medical-device software development, quality, or regulatory, including at least one Class II (ideally Class III) device taken through design controls and an FDA 510(k) (or PMA).
• Hands-on authorship of IEC 62304 deliverables across the full life cycle, including Class C software.
• Working command of ISO 14971 risk management as applied to software.
• Practical experience with 21 CFR 820.30 design controls and ISO 13485 / QMSR; able to operate inside a manufacturer's existing QMS.
• Direct experience preparing software documentation for an FDA 510(k), per the FDA guidance “Content of Premarket Submissions for Device Software Functions” (2023), including Basic vs Enhanced Documentation Level.
• Software V&V expertise: verification strategy, test protocol/report authoring, and end-to-end traceability (requirements-management tooling / traceability matrix).
• Medical-device cybersecurity documentation: threat modeling, SBOM, and SOUP management per current FDA premarket cybersecurity guidance.
• Familiarity with human factors / usability engineering (IEC 62366-1; FDA HF guidance).
• Technical literacy sufficient to review a Python / C++ Linux codebase, architecture, and code-level traceability, and to converse credibly with developers.
• Excellent technical writing and documentation discipline; experience building and maintaining a Design History File.
• Strong communication to interface with a US device manufacturer's RA/QA team across time zones.

4. Preferred / nice-to-have

• Domain experience with surgical navigation, computer-assisted surgery, or image-guided / stereotaxic systems (the OLO space): registration, tracking, coordinate frames, and how to verify geometric / tracking accuracy.
• Orthopedic / total-joint exposure.
• AI/ML in SaMD: familiarity with FDA's AI-enabled device software guidance, Good Machine Learning Practice, and handling of off-the-shelf AI components.
• Experience with AAMI TIR45 (agile development of medical-device software) and TIR57 (cybersecurity risk management).
• Certifications: RAC- Devices (RAPS.
• Prior involvement in a cleared navigation or robotics 510(k).

5. Standards & regulations the candidate must know

A qualified candidate should be fluent in the following; naming these in the job post helps filter applicants:

• IEC 62304 — medical device software life-cycle processes.
• ISO 14971 — risk management for medical devices.
• ISO 13485 / FDA QMSR (21 CFR 820) — quality system and design controls.
• 21 CFR 882.4560 (OLO) and 892.2020 (LMD) — the applicable device regulations.
• FDA premarket software & cybersecurity guidance (2023) and FD&C Act •524B.
• IEC 62366-1 and FDA human-factors guidance — usability engineering.
• AAMI TIR45 / TIR57; plus system-level awareness of IEC 60601-1.

6. Deliverables the role owns or co-owns

Software Development Plan; software requirements specification; software architecture & detailed design; V&V protocols and reports; traceability matrix; SOUP list and SBOM; software cybersecurity documentation; human-factors / usability inputs; configuration-management plan; problem-resolution records; and the DHF-ready software documentation package, including the software sections of the 510(k).

7. Boundary with Restor3d

Restor3d owns the device risk file (ISO 14971), the software safety classification, clinical validation, the FDA 510(k) / regulatory submission, Design History File ownership, and the quality management system. This specialist is responsible for ensuring Capital Numbers' software design-control and V&V outputs satisfy those obligations and integrate cleanly into Restor3d's DHF and submission. The role has the authority and allocated time to enforce process — it is a dedicated project resource, not a part-time reviewer.

9. Role titles & engagement

Likely titles: Medical Device Software Quality & Regulatory Engineer • Software Design Assurance / V&V Engineer (Medical Devices) • Regulatory & Compliance Lead — Medical Device Software.

Engagement: a full-time embedded hire for the project duration, or a senior consultant with sufficient allocation to own and enforce the design-control and V&V process from project start through 510(k)-ready documentation