Design Assurance Engineer II

Design Assurance Engineer II
Location: Greater Boston area (onsite/hybrid)

We're working with an innovative medical device company to hire a Design Assurance Engineer II to support product development from early concept through manufacturing transfer.

This role sits within Quality and partners closely with R&D, offering hands‑on exposure to design assurance activities, risk management, and post‑market quality processes.

What you'll be responsible for:

• Support new product development as the Quality/Design Assurance representative on one or more development programs
• Contribute to design assurance activities including risk management, design reviews, and V&V planning and execution
• Participate in R&D testing, statistical analysis, and data interpretation
• Lead or support cross‑functional complaint investigations and root cause analysis
• Assist with complaint trending, metrics, and data visualization (Excel, dashboards, etc.)
• Support CAPA management, including facilitating root cause analysis and maintaining timelines
• Execute corrective actions to address nonconformances and product issues
• Review and support document and design changes
• Ensure all activities comply with applicable medical device regulations and internal quality system requirements

Background requirements:

• Bachelor's degree in engineering, science, or a related discipline
• 3-5 years of experience in design assurance or quality engineering roles within the medical device industry
• Working knowledge of risk management tools and methodologies (FMEA, fault tree analysis, etc.)
• Familiarity with FDA regulations and ISO 13485
• Comfortable with basic statistics and data analysis; experience with tools like Excel, Minitab, or Tableau a plus
• Strong analytical skills and attention to detail
• Able to collaborate in a fast‑paced, small‑company environment
• Clear written and verbal communicator with a strong sense of ownership and professionalism

Why this role:

• Broad exposure across design assurance, risk management, and post‑market quality
• Opportunity to work closely with R&D on meaningful product development programs
• High‑impact role within a growing, collaborative medical device environment