Design Quality Engineer II

Title: Design Assurance Engineer II

Location: Hybrid in Bedford, MA

Summary

A growing medical technology organization is seeking a Design Assurance Engineer II to support product development, risk management, complaint investigation, and CAPA activities. This role partners closely with R&D from early concept through manufacturing transfer and helps ensure products meet quality and regulatory requirements.

Key Responsibilities

• Support new product development with risk management, V&V planning/execution, design reviews, and statistical analysis.
• Lead or support complaint investigations and root cause analysis; contribute to product improvement initiatives.
• Assist with complaint metrics, data analysis, and visualization (Excel, Tableau).
• Manage or support CAPAs, ensuring timely root cause analysis and effective corrective actions.
• Review design and document changes for quality compliance.
• Perform all work in accordance with relevant regulations, quality system requirements, and internal procedures.

Qualifications

• Bachelor's degree in engineering, science, or related field.
• 3-5+ years in design assurance, quality engineering, or product development in the medical device industry.
• Experience with FMEA, fault tree analysis, and risk management tools.
• Strong computer skills (Office Suite, Adobe, Minitab; Tableau a plus).
• Knowledge of FDA regulations and ISO 13485.
• Strong analytical skills, attention to detail, and ability to manage multiple tasks.
• Effective communicator and collaborative team player with high professionalism and integrity.

If this sounds of interest, please apply in for more information!