10+ years in Quality Engineering for regulated medical devices (Class II/III preferred)
Hands-on experience with design controls and DHF management
Knowledge of medical device standards (e.g., 21 CFR 820, ISO 13485)
Understanding of software quality in SDLC and risk management
Proven use of risk management tools (e.g., FMEA)
Experienced in defending quality documentation during audits
Strong analytical and communication skills across teams
Familiarity with eQMS/PLM tools and defect management processes
Responsibilities
Serve as the quality lead in product development teams ensuring design control compliance
Establish and maintain Design History Files (DHF) and Device Master Records (DMR)
Lead risk management activities and integrate risk controls into design
Oversee software SDLC compliance and its integration with risk management
Review design and software deliverables for completeness and audit readiness
Support verification and design transfer aligning outputs with production
Lead CAPA and nonconformance investigations for continuous improvement
Assist in internal and external audits and regulatory submissions
Benefits
Opportunity to work in a cutting-edge medical device environment
Collaborative cross-functional teamwork that drives innovation
Engagement in the full product development lifecycle
Focus on compliance with high regulatory standards
Chance to develop expertise in risk management for medical software
Access to a supportive management team dedicated to quality improvements
Full Job Description
Job Description
As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products.
Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post-market activities.
Key Responsibilities In this role you will play a key role in:
Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)
Required Skills
10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
Experience supporting software quality within the SDLC and understanding of software risk management principles
Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes
