Staff Software Quality Engineer - Medical Device Compliance

EnChannel Medical LTD; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

EnChannel Medical is seeking a Quality Engineer, Staff (Software) to lead remediation of software design controls and to structure the Design History File for regulatory readiness. You will collaborate with software, hardware, clinical, and regulatory teams to ensure traceability, risk management, and compliant artifacts for FDA/EU MDR submissions.

The role emphasizes hands-on execution, working under Quality leadership to translate strategy into auditable deliverables and to support inspections

Qualifications

• Bachelor’s degree in Engineering, CS, or related field.
• 5+ years software quality engineering in medical devices.
• Experience remediating software design documents and DHF restructuring.
• Experience supporting FDA submissions or regulatory inspections.
• Knowledge of FDA Design Controls and lifecycle documentation.
• Familiar with IEC 62304, IEC 62366, and FDA guidance.

Responsibilities

• Lead software design controls remediation and DHF structuring.
• Collaborate with software and R&D to produce design inputs/outputs, verification, and traceability.
• Identify risks and support regulatory timelines and submissions.
• Support FDA inspections and audits with evidence and regulator-facing docs.
• Escalate gaps with evidence-based recommendations.
• Ensure alignment with IEC 62304/62366 and FDA guidance.

Skills

Software Quality Engineering

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering/CS

Tools

DHF restructuring

FDA 21 CFR 820

IEC 62304

IEC 62366

FDA Software Validation

Job description

EnChannel Medical is seeking a Quality Engineer, Staff (Software) to lead remediation of software design controls and to structure the Design History File for regulatory readiness. You will collaborate with software, hardware, clinical, and regulatory teams to ensure traceability, risk management, and compliant artifacts for FDA/EU MDR submissions.

The role emphasizes hands-on execution, working under Quality leadership to translate strategy into auditable deliverables and to support inspections