Senior Design Quality Assurance Engineer

RiseMe; South Carolina; Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific in Marlborough, MA seeks a Design Quality Assurance Engineer III to provide quality engineering across the product lifecycle, partnering with R&D, Operations, Regulatory, and Manufacturing to ensure safety, compliance, and patient outcomes.

You'll lead design change projects, maintain Design History Files, guide risk management, develop verification and validation protocols, support CAPAs and audits, and drive continuous improvement in quality and cost effectiveness through

Qualifications

• Bachelor's degree in Engineering or related technical discipline is required.
• Minimum 5 years of experience in Design Assurance, Quality Engineering, Product Development, or a related role within a regulated industry.
• Knowledge of Design Controls, Risk Management, Quality Systems, and Good Documentation Practices.
• Strong analytical, technical writing, communication, and problem-solving skills.
• Experience working effectively within cross-functional teams.

Responsibilities

• Provide quality engineering support for new product development, product enhancements, design transfers, design changes, and sustaining engineering projects.
• Partner with cross-functional teams to ensure compliance with Product Development Process, Design Controls, Risk Management, and applicable Quality System requirements.
• Lead or support design change projects including project scoping, impact assessment, implementation, and effectiveness verification.
• Develop, review, update, and maintain Design History File documentation and design input/output records.
• Lead or support risk management activities including Hazard Analyses, Use-Related Risk Analyses, Task Analyses, Design FMEAs, and benefit-risk assessments.
• Develop and execute Design Verification, Design Validation, Usability, and other qualification protocols and reports.
• Serve as a quality representative on project teams, providing guidance on quality system requirements, design controls, standards compliance, and regulatory expectations.
• Support investigations and resolution of complaints, nonconformances, CAPAs, product investigation reports, audit observations, field actions, and supplier quality issues.
• Apply structured problem-solving methodologies to identify root causes, assess risk, and implement effective corrective actions.
• Monitor post-market data, complaint trends, and product performance signals to assess risk and drive quality improvements.
• Support supplier qualification, audits, co-development activities, and ongoing supplier performance monitoring.
• Participate in internal, external, customer, and regulatory audits and inspection readiness activities.
• Drive continuous improvement initiatives focused on product quality, manufacturability, reliability, compliance, and cost effectiveness.

Skills

Analytical thinking

Technical writing

Communication

Problem-solving

Cross-functional collaboration

Quality mindset

Education

Bachelor's degree in Engineering

Biomedical/Mechanical/Electrical engineering

Job description

Boston Scientific in Marlborough, MA seeks a Design Quality Assurance Engineer III to provide quality engineering across the product lifecycle, partnering with R&D, Operations, Regulatory, and Manufacturing to ensure safety, compliance, and patient outcomes.

You'll lead design change projects, maintain Design History Files, guide risk management, develop verification and validation protocols, support CAPAs and audits, and drive continuous improvement in quality and cost effectiveness through