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