Senior Medical Device Software Quality Engineer

Philips; Bedford (MA); On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO (paid time off)

401k match

Stock purchase plan

Job summary

Philips seeks a Software Design Assurance Engineer to develop and maintain software quality documentation, ensuring regulatory compliance throughout the software lifecycle.

You will lead design assessment, apply quality policies, track anomalies, perform root-cause analyses, and manage regulatory planning and registrations for global market access. Requires 5+ years in FDA/regulatory environments and a Bachelor’s in Quality/CS/Engineering.

Qualifications

• The role requires 5+ years in FDA-regulated medical device software environments.
• Experience with Risk Management (ISO 14971) and software design controls.
• Proficiency in software V&V, design traceability, and SDLC methodologies.

Responsibilities

• Lead assessment of software designs using test and performance data.
• Apply and improve software design verification, risk management, and cyber security controls.
• Track software anomalies and conduct root cause analyses for quality issues.
• Develop and execute software test protocols and generate reports.
• Oversee regulatory planning and filings for global registrations.

Skills

Regulatory compliance

Software quality

Root cause analysis

SDLC knowledge

Communication skills

Education

Bachelor’s Degree in Quality/CS/Engineering

Tools

C/C++

C#

Job description

Philips seeks a Software Design Assurance Engineer to develop and maintain software quality documentation, ensuring regulatory compliance throughout the software lifecycle.

You will lead design assessment, apply quality policies, track anomalies, perform root-cause analyses, and manage regulatory planning and registrations for global market access. Requires 5+ years in FDA/regulatory environments and a Bachelor’s in Quality/CS/Engineering.