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!
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