Design Assurance Engineer II
EPM Scientific, Boston, MA, United States
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
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
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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
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
#J-18808-Ljbffr