Senior Design Quality Engineer

Katalyst CRO; Andover (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Senior Design Quality Engineer to ensure design quality compliance for medical devices in the Greater Boston area. The role requires leadership on product development teams, ensuring adherence to design controls and risk management throughout the product lifecycle.

The ideal candidate will have over 10 years of relevant experience, extensive knowledge of applicable standards, and the ability to work cross-functionally while supporting audits and regulatory submissions.

Qualifications

• 10+ years of experience in Quality Engineering supporting regulated medical device development.
• Strong hands-on experience with design controls and DHF management.
• Proven experience with risk management tools and integration into product development.

Responsibilities

• Ensure compliance with design controls across all lifecycle phases.
• Lead and maintain risk management activities.
• Support internal and external audits and regulatory submissions.

Skills

Design controls

DHF management

Risk management

Software SDLC

FMEA

Quality documentation

Regulatory compliance

Education

Bachelor's degree in Engineering

Advanced degree in Engineering, Quality, or Regulatory Affairs

Relevant certifications (e.g., ASQ CQE, CSQE)

Tools

eQMS/PLM tools

Defect tracking tools

Job description

Summary

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.

Roles & Responsibilities

• 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)

Education & Experience

• 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
• 10+ years of experience in software quality assurance within regulated environments (medical device preferred)
• Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements
• Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)
• Proven experience reviewing and improving SOPs or quality processes for regulatory compliance
• Hands on experience with software verification and validation using risk-based approaches aligned with FDA expectations
• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)
• Experience with test management, defect tracking, and quality documentation tools
• Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions
• Bachelor's degree in Engineering (Biomedical, Software, Systems) or a related technical discipline
• Advanced degree (Masters) in Engineering, Quality, or Regulatory Affairs preferred
• Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus