Job Title: Design Assurance Engineer (Medical Devices)

Location: Middlesex, MA (Onsite)

Overview

Seeking experienced Design Assurance Engineers to support remediation activities for electromechanical medical devices. The role focuses on Design History File (DHF) updates, design controls, and quality compliance. Ideal candidates are proactive, hands-on, and capable of working in a fast-paced, matrixed environment.

Required Experience

• 6+ years in Design Assurance, Design Quality, or related engineering roles within the medical device industry .
• Strong knowledge of design controls , DHF maintenance , risk management (ISO 14971) , and V&V documentation .
• Experience working with electromechanical medical devices .
• Exposure to software documentation (application-level; not embedded).
• Prior experience supporting remediation , FDA 483 , Warning Letters , or quality system upgrades is preferred.
• Ability to work cross-functionally and independently in large, fast-paced organizations.

Key Responsibilities

• Support remediation activities related to FDA findings, including DHF updates, documentation corrections, and closing design control gaps.
• Review and update design control documentation, risk management files (ISO 14971), and verification/validation deliverables.
• Collaborate with R&D, Quality, Regulatory, and Systems teams to gather missing information and ensure audit-ready documentation.
• Provide technical input on electromechanical device design, system interactions, and software-related documentation (application-level).
• Ensure alignment with 21 CFR Part 820, ISO 13485, and internal quality system requirements.
• Contribute to process improvements within design assurance and product development quality.