Software Design Quality Engineer
PhilipsMassachusetts, United States
Posted March 30, 2026
102480 - 163968 USD
Full Time
About the Company
Philips is a health technology company that believes every human matters and strives to provide quality healthcare to everyone everywhere.
Job Description
The Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle. The role involves leading the assessment of software designs, tracking and risk assessing software anomalies, and implementing software quality plans and risk management activities.
Requirements
- Minimum of 5+ years' experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control
- Detailed knowledge of Risk Management (ISO 14971), SDLC and strong Understanding of all aspects of the QMS related to Software Design Controls
- Proven experience in Root Cause Analysis, Software V&V, identifying/supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
