Design Quality Engineer

Design Quality Engineer

Location: Marlborough, MA

Expected Duration: Early November 2026 through December 2027

Position Overview

We are seeking a Design Quality Engineer to support Design History File (DHF) remediation and Design Controls initiatives within a regulated medical device environment. This individual will partner with Quality, R&D, Regulatory Affairs, and other cross-functional stakeholders to assess, remediate, and strengthen design control documentation across legacy and active product portfolios.

The ideal candidate is a self-driven quality professional with strong technical writing skills, sound judgment, and a hands-on approach to resolving documentation gaps. This role requires the ability to navigate incomplete information, independently identify compliance gaps, develop practical solutions, and drive remediation activities through completion while maintaining a high standard of quality and regulatory compliance.

Key Responsibilities

• Review and assess existing Design History Files (DHFs) to identify documentation gaps, inconsistencies, and compliance risks.
• Develop and execute remediation strategies for design inputs, design outputs, design verification, design validation, design reviews, risk management, and traceability documentation.
• Author, revise, and review design control documentation and quality records to ensure completeness, accuracy, consistency, and audit readiness.
• Partner with cross-functional teams to reconstruct product development history and establish objective evidence supporting design decisions.
• Develop and maintain requirements traceability matrices and supporting design control documentation packages.
• Support risk management activities, including design FMEAs, hazard analyses, and risk/benefit assessments.
• Interpret and apply FDA, ISO 13485, ISO 14971, and internal quality system requirements within remediation activities.
• Collaborate with global stakeholders to align on remediation strategies, resolve documentation challenges, and drive deliverables to closure.
• Support internal audits, inspections, and remediation effectiveness reviews as required.
• Identify opportunities to improve remediation processes, tools, and methodologies, increasing efficiency while maintaining compliance.

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
• 3–5 years of experience in the medical device industry or another regulated environment.
• Working knowledge of design controls, risk management, and product development processes.
• Hands-on experience with risk management documentation, including DFMEAs and hazard analyses.
• Familiarity with FDA quality system requirements, ISO 13485, ISO 14971, and applicable medical device regulations.
• Strong technical writing skills and the ability to develop clear, accurate, and compliant documentation.
• Demonstrated ability to independently manage multiple priorities and deliver high-quality work with minimal supervision.
• Strong analytical, organizational, critical-thinking, and problem-solving skills.
• Effective communication and collaboration skills when working with cross-functional and global teams.

Preferred Qualifications

• Direct experience with DHF remediation, Design Assurance, Design Quality Engineering, or design control compliance initiatives.
• Experience supporting remediation programs, regulatory commitments, audit findings, or CAPA-related activities.
• Knowledge of traceability methodologies and requirements management.
• Experience supporting Class II or Class III medical device product development, preferably within Endoscopy.
• Working knowledge of design control requirements under 21 CFR Part 820 and ISO 13485.