Design Quality Engineer

Overview

Job Title: Software Design Quality Engineer (Firmware & System Software)

Location: Massachusetts

Work Mode: Onsite

Job Overview:

We are seeking an experienced Software Design Quality Engineer to support firmware and system-level software development for a next-generation capital equipment platform. This role focuses on design quality, risk management, and regulatory compliance across the full software development lifecycle. The ideal candidate is technically strong, understands firmware design concepts, and can effectively support quality activities without being a hands-on firmware developer.

• Support early-phase software development activities, including design quality planning and execution.
• Partner with firmware and system software teams on a next-generation console program.
• Generate and review software-based FMEAs derived from Software Requirement Specifications, with a strong focus on patient safety risk management.
• Support design changes through formal Change Control Board (CCB) processes, ensuring compliance with applicable regulatory and quality standards.
• Participate in Agile/SCRUM activities, including sprint planning, sprint cycles, and daily stand-ups.
• Support and execute risk management activities throughout the product lifecycle.
• Review software test protocols, test reports, and validation documentation.
• Conduct software code reviews and design reviews to ensure design quality and compliance.
• Support cybersecurity and software risk assessments.
• Collaborate cross-functionally with engineering, quality, and regulatory teams to ensure successful product development and release.

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline.
• Minimum 5 years of experience in medical device software quality engineering (8+ years preferred).
• Strong knowledge of medical device software quality standards, including IEC 14971, IEC 62304, and ISO 13485.
• Experience supporting firmware and system-level software development activities.
• Solid understanding of software design inputs and requirements management.
• Experience with capital equipment and Software as a Medical Device (SaMD).
• Hands-on experience using JAMA for requirements management.
• Proficiency with JIRA for issue tracking and Agile workflows.
• Experience working in Agile/SCRUM development environments.
• Technically savvy, with the ability to understand firmware design concepts and system architecture.
• Basic understanding of cybersecurity principles as they relate to medical device software.

• Experience supporting next-generation or complex medical device platforms.
• Strong background in patient safety and risk-based design decision making.
• Prior involvement in regulatory submissions and design history file (DHF) activities.
• Experience supporting cybersecurity risk assessments in regulated environments.