Medical Device Software Quality Engineer – Regulatory & V&V

Mass Digital Health; Massachusetts; On-site; USD 102,000 - 164,000; Full time

Job summary

Philips is hiring a Software Design Quality Engineer in Bedford, MA for an on-site, full-time role. You will lead software design assessment, verification, and validation activities to ensure safety, quality and regulatory compliance throughout the lifecycle.

You will drive risk management (ISO 14971), traceability, cyber security risk management, and post-market analytics. A bachelor’s degree and strong communication skills are required; salary ranges reflect market at Bedford, MA.

Qualifications

• Minimum 5+ years in FDA regulated, IEC 62304 medical device software environments.
• Detailed knowledge of ISO 14971 Risk Management.
• Strong understanding of SDLC and QMS for Software Design Controls.
• Experience with software design assurance, testing, and validation.

Responsibilities

• Lead assessment of software designs using test and performance data to uphold quality, safety, and regulatory standards.
• Oversee software design verification, validation, risk management, traceability, and cyber security risk management.
• Track and assess software anomalies for pre- and post-market medical device software.
• Conduct root cause analyses for quality issues and validate usability, reliability, and performance.
• Author and execute software test protocols and generate test reports.
• Implement quality plans and risk management activities; monitor performance with post-market analytics.
• Oversee regulatory planning and submissions for global registrations for market access.
• Drive regulatory excellence and continuous improvement of processes and efficiency.

Skills

FDA regulated

Software Design Assurance

Risk Management

SDLC

QMS for Software Design

Root Cause Analysis

Software V&V

Agile/SAFe

C/C++/C#

Communication skills

Education

Bachelor’s Degree in Quality/CS/Engineering

ISTQB certification

Job description

Philips is hiring a Software Design Quality Engineer in Bedford, MA for an on-site, full-time role. You will lead software design assessment, verification, and validation activities to ensure safety, quality and regulatory compliance throughout the lifecycle.

You will drive risk management (ISO 14971), traceability, cyber security risk management, and post-market analytics. A bachelor’s degree and strong communication skills are required; salary ranges reflect market at Bedford, MA.