Senior Design Quality Engineer

Job Description -

Role name: Senior Design Quality Engineer

Work Location: Andover, MA (Hybrid 3 days onsite)

Duration: 3 Months (C2H)

Qualifications:

o Bachelor s degree in Engineering (Biomedical, Software, Systems) or a related technical discipline

o Advanced degree (Master s) in Engineering, Quality, or Regulatory Affairs preferred

o Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus

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