Medical Device Risk & Quality Lead (Software Focus)

Axoft; Cambridge (MA); On-site; USD 120,000 - 165,000; Full time

Job summary

Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own Axoft’s organizational risk management system across product design, development processes, and software. The immediate priority is software risk, with broader risk management support as the device and quality system mature.

The role requires hands-on FMEA or structured risk assessment experience in regulated industries, familiarity with ISO 14971, and capability to engage with engineers while maintaining

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.

Responsibilities

• Design risk assessments (dFMEA).
• Process risk assessments (pFMEA).
• Software Risk Assessment (SRA).
• Cybersecurity Risk Analysis (CRA).
• Triage anomalies for safety and cybersecurity impact; drive disposition decisions and quality remediation of serious issues.
• Maintain audit‑ready quality records and support regulatory inspections and internal audits of the product development process.

Skills

FMEA

Structured risk assessment

Software literacy

Regulatory understanding

Written communication

Tools

QMS documentation

Document control

Change management

Audit preparation

Supplier qualification

CAPA handling

Job description

Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own Axoft’s organizational risk management system across product design, development processes, and software. The immediate priority is software risk, with broader risk management support as the device and quality system mature.

The role requires hands-on FMEA or structured risk assessment experience in regulated industries, familiarity with ISO 14971, and capability to engage with engineers while maintaining