Senior Design Quality Assurance Engineer

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

Benefits offered by this job

Relocation assistance available

Job summary

Boston Scientific Marlborough, MA is seeking a Design Quality Assurance Engineer III to provide quality engineering support across the product lifecycle, including development, transfers, sustaining engineering, and post-market activities.

This role partners with R&D, Operations, Regulatory, Clinical, and Marketing to ensure patient safety and product quality, with a strong emphasis on risk-based decision making and continuous improvement.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• Minimum 4 years in design assurance, quality engineering, or similar in regulated industry.
• Knowledge of design controls, risk management, quality systems and GxP practices.
• Strong analytical, writing, communication, and problem-solving skills.
• Experience working effectively in cross-functional teams.

Responsibilities

• Provide quality engineering support for new product development, 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 Quality System requirements.
• Lead or support design change projects including scoping, impact assessment, implementation, and verification of effectiveness.
• 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, 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, guiding on quality system requirements and regulatory expectations.
• Support investigations and resolution of complaints, nonconformances, CAPAs, product investigations, audit observations, field actions, and supplier quality issues.

Skills

Design Assurance

Quality Engineering

Regulatory knowledge

Risk Management

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in Engineering

Job description

Boston Scientific Marlborough, MA is seeking a Design Quality Assurance Engineer III to provide quality engineering support across the product lifecycle, including development, transfers, sustaining engineering, and post-market activities.

This role partners with R&D, Operations, Regulatory, Clinical, and Marketing to ensure patient safety and product quality, with a strong emphasis on risk-based decision making and continuous improvement.