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.
- bility 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.
- dvanced 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.
