Job Description:
As a Senior Design Quality Engineer 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. 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.
Responsibilities:
Serving as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls(specifically software) 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.
Responsible for 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.
Responsible for 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).
Education and experience:
Mandatory experience supporting software quality within the SDLC and understanding of software risk management principles.
Experience participating in software design reviews, software architecture reviews, and assessment of software lifecycle deliverables including requirements, architecture/design documentation, traceability, verification, and validation evidence.
10+ 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 QMS supporting Software Design Controls.
Strong experience with complex medical systems for connected/embedded technologies.
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.
Experience supporting software-related regulatory submissions and audits (e.g., IDE, PMA, 510(k), EU MDR) and defending software quality and design control documentation.
Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams.
Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements.
Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline.
Advanced degree (Master's) in Engineering, Quality, or Regulatory Affairs preferred.
Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus.
