Medical Device Software Quality Engineer

Philips International; Tennessee; On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

Total Rewards benefits

PTO

401k

HSA

Stock plan

Job summary

Philips is seeking a Software Design Quality Engineer in the US to lead software quality activities across the lifecycle, review designs, perform risk assessments, and ensure regulatory compliance for medical device software.

You will apply software testing, V&V, traceability, and design for quality principles, collaborate with multi-disciplinary teams, and drive continuous improvement while meeting FDA and IEC 62304 requirements.

Bachelor's degree and ISTQB desired; US residency required.

Qualifications

• Experience in FDA-regulated medical device software environments.
• Knowledge of ISO 14971 risk management and IEC 62304 SDLC.
• Ability to perform root cause analysis and drive corrective actions.

Responsibilities

• Lead software design assessment and risk management activities.
• Author and execute software test protocols with traceability.
• Ensure regulatory planning and submissions for global registrations.

Skills

FDA regulated experience

Software Design Assurance

Root Cause Analysis

C/C++ knowledge

Regulatory knowledge

Education

Bachelor's Degree in Quality/Engineering/CS

Tools

Software V&V

ISO 14971

SDLC

Job description

Philips is seeking a Software Design Quality Engineer in the US to lead software quality activities across the lifecycle, review designs, perform risk assessments, and ensure regulatory compliance for medical device software.

You will apply software testing, V&V, traceability, and design for quality principles, collaborate with multi-disciplinary teams, and drive continuous improvement while meeting FDA and IEC 62304 requirements.

Bachelor's degree and ISTQB desired; US residency required.