Design, Process, and Software Quality Risk Specialist

Axoft•Cambridge, MA

3d•$140,000 - $150,000

About The Position

Axoft is building a new class of implantable neural interface—ultra-flexible, minimally reactive, and designed to remain functional for decades inside the human brain. Our software connects that hardware to the world: acquisition firmware, embedded configuration tools, clinical monitoring applications, and the cloud infrastructure that ties them together. Every release we ship ultimately affects a patient. We are a small, technical team building compliant medical device systems the right way: risk-driven, Agile, and grounded in the international standards that governs product development, quality systems, and medical device software globally. We are looking for someone to help own the organizational risk management infrastructure that makes that possible, with software risk as the immediate priority.

Requirements

2–4 years of direct experience conducting FMEA or another structured risk assessment methodology in medical devices, aerospace, automotive, industrial, or another regulated industry where you were responsible for identifying failure modes, evaluating severity and probability, and defining controls.
Practical experience managing elements of a formal QMS: document control, change management, audit preparation, supplier qualification, nonconformance or CAPA handling; industry does not matter as long as you have worked inside a real quality system rather than just alongside one.
Software literacy sufficient to read a requirements document, understand a system architecture diagram, and evaluate whether a risk control measure is implemented and tested appropriately; this can come from engineering experience, a technical degree, or a background in DevSecOps or security engineering.
Familiarity with ISO 14971 or a closely analogous risk management framework; you understand the structure of hazard analysis and how risk control measures are documented and verified.
Strong written communication; you can produce clear, specific, well-reasoned risk and quality documentation that stands up to regulatory scrutiny.

Nice To Haves

Familiarity with ISO 13485 quality management systems and FDA QMSR.
Experience with IEC 62304 medical device software lifecycle processes: software safety classification, required documentation by class, and how development and verification activities trace to risk controls
Experience with AAMI SW96, IEC 81001-5-1, or cybersecurity risk management in another regulated context
Familiarity with CVSS or other methods of scoring security vulnerabilities.
Experience in Threat Modeling using STRIDE

Responsibilities

Design risk assessments (dFMEA)
Process risk assessments (pFMEA)
Software Risk Assessment (SRA)
Cybersecurity Risk Analysis (CRA)
Software QMS management. Track and manage changes to software requirements and design documents.
Phase review coordination.
Cybersecurity threat modeling.
Software complaint management.
Triage anomalies for safety and cybersecurity impact, drive disposition decisions, and manage quality remediation of serious issues.
Maintain audit-ready quality records and support regulatory inspections and internal audits of the product development process.
Software Complaint management: Triage anomalies for safety and cybersecurity impact, drive disposition decisions, and manage quality remediation of serious issues
Maintain audit-ready quality records and support regulatory inspections and internal audits of the product development process