Design Quality Assurance Engineer III - Impact & Compliance

Boston Scientific; Marlboro (MA); Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific in Marlborough, MA is seeking a Design Quality Assurance Engineer III to provide quality engineering support across the product lifecycle, from new product development to post-market activities. You will collaborate with R&D, Operations, Regulatory, and Marketing to ensure safety, effectiveness, and regulatory compliance.

The role emphasizes risk-based decision making, CAPA, design controls, and continuous improvement.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• At least 4 years of experience in Design Assurance/Quality Engineering in 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

Quality engineering

Design controls

Risk management

Technical writing

Problem solving

Cross-functional teams

Data analysis

Education

Bachelor's degree in Engineering

Mechanical/Electrical/Biomedical engineering

Job description

Boston Scientific in Marlborough, MA is seeking a Design Quality Assurance Engineer III to provide quality engineering support across the product lifecycle, from new product development to post-market activities. You will collaborate with R&D, Operations, Regulatory, and Marketing to ensure safety, effectiveness, and regulatory compliance.

The role emphasizes risk-based decision making, CAPA, design controls, and continuous improvement.