Medical Device Software Risk & Quality Lead

Socket.dev; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own organizational risk management across product design, development processes, and software. The role prioritizes software risk but supports risk management across the organization as the device and quality system mature.

Ideal candidates have hands-on experience with FMEA or structured risk assessment, some grounding in quality systems, and sufficient software literacy to engage engineers.

Qualifications

• 2-4 years of direct experience conducting FMEA or another structured risk assessment methodology in regulated industries
• Practical experience managing elements of a formal QMS: document control, change management, audit preparation, supplier qualification, CAPA handling
• Software literacy sufficient to read a requirements document, understand a system architecture diagram, and evaluate risk controls
• Familiarity with ISO 14971 or a closely analogous risk management framework; understanding hazard analysis and risk control documentation
• Strong written communication; ability to produce clear, regulatory-grade 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, and manage quality remediation of serious issues
• Maintain audit-ready quality records and support regulatory inspections and internal audits of the product development process

Skills

FMEA experience

QMS management

Software literacy

ISO 14971

Strong written communication

ISO 13485 familiarity

IEC 62304 familiarity

CVSS / STRIDE knowledge

Job description

Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own organizational risk management across product design, development processes, and software. The role prioritizes software risk but supports risk management across the organization as the device and quality system mature.

Ideal candidates have hands-on experience with FMEA or structured risk assessment, some grounding in quality systems, and sufficient software literacy to engage engineers.