Medical Device Software Quality Engineer

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

Job summary

Philips in Bedford, MA is seeking a Software Design Quality Engineer to ensure regulatory compliance and robust software quality throughout the lifecycle. You will lead design reviews, risk management, verification activities, and testing protocols for medical device software in FDA/IEC 62304 environments.

You will perform root cause analysis, support regulatory filings, and drive continuous improvement in software design controls, traceability, and quality assurance across hardware and software

Qualifications

• 5+ years’ experience in FDA regulated, IEC 62304 medical device software environments with focus on Software Design Assurance/Control.
• Strong knowledge of Risk Management (ISO 14971), SDLC and QMS related to Software Design Controls.
• Experience in Root Cause Analysis, Software V&V, defects tracking, design traceability, Design for Quality (DfQ), Agile, SAFe.
• Experience with complex medical systems containing software, hardware and disposables.
• Ability to communicate regulatory requirements and software quality standards effectively.
• Excellent written and verbal communication skills for all management levels.
• Bachelor’s degree required; ISTQB certification desired.
• Must meet physical, cognitive and environmental job requirements.

Responsibilities

• Lead assessment of software designs by reviewing test data to uphold quality, safety, and regulatory standards.
• Apply and improve policies related to software development and validation including design verification, risk management, and systems validation.
• Track and risk assess software anomalies for pre- and post-market medical device software.
• Conduct root cause analyses for software quality issues and validate key design inputs such as usability and performance.
• Assess products to identify defects by authoring/executing test protocols and generating reports.
• Implement software quality plans and risk management activities; monitor performance with post-market analytics.
• Ensure lifecycle regulatory planning and execution for new products/changes; manage filings and approvals for global registrations.
• Drive regulatory excellence and continuous improvement by developing plans and optimizing processes.

Skills

Software quality

Regulatory compliance

Root Cause Analysis

Software Design Assurance

SDLC

Communication

Education

Bachelor’s degree

ISTQB certification desired

Tools

C/C++/C#

Job description

Philips in Bedford, MA is seeking a Software Design Quality Engineer to ensure regulatory compliance and robust software quality throughout the lifecycle. You will lead design reviews, risk management, verification activities, and testing protocols for medical device software in FDA/IEC 62304 environments.

You will perform root cause analysis, support regulatory filings, and drive continuous improvement in software design controls, traceability, and quality assurance across hardware and software