Senior Design Quality Assurance Engineer

Boston Scientific; Marlborough (MA); On-site; USD 82,000 - 156,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific in Marlborough, MA is seeking a Design Quality Assurance Engineer III to provide quality engineering support across the product lifecycle, including NPD, design transfer, sustaining engineering, and post-market activities. You’ll partner with R&D, Operations, Regulatory, and Marketing to ensure safe, compliant, and effective medical devices.

The role emphasizes risk-based decision making, CAPA handling, and continuous improvement, with a hybrid on-site expectation of at least

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 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.

Skills

Quality Engineering

Design Controls

Risk Management

CAPA

Regulatory Knowledge

Education

Bachelor's degree in Engineering

Tools

Quality Systems

FDA Regulations

Job description

Boston Scientific in Marlborough, MA is seeking a Design Quality Assurance Engineer III to provide quality engineering support across the product lifecycle, including NPD, design transfer, sustaining engineering, and post-market activities. You’ll partner with R&D, Operations, Regulatory, and Marketing to ensure safe, compliant, and effective medical devices.

The role emphasizes risk-based decision making, CAPA handling, and continuous improvement, with a hybrid on-site expectation of at least