Medical Device Risk & Quality Systems Specialist

Axoft; Cambridge (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Axoft is building a new class of implantable neural interface with a software stack spanning firmware, embedded configuration tools, clinical monitoring apps, and cloud infrastructure. The Design, Process, and Software Quality Risk Specialist will own the organizational risk management system across design, development processes, and software, with software risk as the immediate priority.

The ideal candidate has hands-on experience with FMEA or structured risk assessment in regulated industries,

Qualifications

• 2–4 years of direct experience conducting FMEA or structured risk assessment in regulated industries.
• Experience managing elements of a formal QMS: document control, change management, audit preparation, supplier qualification, CAPA handling.
• Ability to read requirements documents and system diagrams to evaluate risk controls.
• Familiarity with ISO 14971 or similar risk management framework.
• Strong written communication for regulatory risk and quality documentation.

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.
• Maintain audit-ready quality records and support regulatory inspections and internal audits of the product development process.

Skills

FMEA experience

Software risk assessment

QMS knowledge

ISO 14971 familiarity

STRIDE threat modeling

Education

Technical degree

Tools

STRIDE

Job description

Axoft is building a new class of implantable neural interface with a software stack spanning firmware, embedded configuration tools, clinical monitoring apps, and cloud infrastructure. The Design, Process, and Software Quality Risk Specialist will own the organizational risk management system across design, development processes, and software, with software risk as the immediate priority.

The ideal candidate has hands-on experience with FMEA or structured risk assessment in regulated industries,