Role: Design Assurance Engineers

Location: MA (Onsite)

Job Description:

Client is in need multiple Design Assurance Engineers to support remediation activities related to FDA 483s and/or Warning Letters. These roles will focus heavily on Design History File (DHF) updates, design controls, and quality compliance for electromechanical medical devices. Candidates must be hands-on, proactive, and comfortable working in a fast-paced environment within a large, established medical device organization.

Key Responsibilities

• Support remediation efforts tied to 483/Warning Letter commitments, including DHF updates and documentation corrections.
• Review and update design control documents, risk management files, and verification/validation deliverables.
• Partner with R&D, Quality, and Systems teams to gather missing documentation, close gaps, and ensure compliance with FDA and ISO standards.
• Contribute to improving design assurance processes and ensuring audit-ready documentation.

Qualifications

• 6+ years of experience in Design Assurance, Design Quality, or related engineering roles within the medical device industry.
• Strong background working with electromechanical devices .
• Software experience is a strong (application-level software, not embedded).
• Experience with design controls, DHF maintenance, risk management (ISO 14971), and verification/validation documentation.
• Prior involvement in remediation activities, 483/Warning Letter responses, or quality system upgrades preferred.