Senior Design QA Engineer – Medical Devices

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

Benefits offered by this job

Hybrid work model

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 new product development, design transfer, and post-market activities. The role partners with R&D, Operations, Regulatory Affairs, Clinical, and Marketing teams to ensure products are safe, effective, compliant, and meet customer needs.

The engineer will lead or support design change projects, maintain DHF documentation, and drive

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 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.
• Experience with FDA QSRs, ISO 13485, and medical device standards is preferred.

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 Quality System requirements.
• Lead or support design change projects including scoping, impact assessment, implementation, and verification.
• Develop and maintain Design History File documentation and design input/output records.
• Lead or support risk management activities including Hazard Analyses, Use-Related Risk 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, guiding on quality system requirements, design controls, and regulatory expectations.
• Support investigations and resolution of complaints, nonconformances, CAPAs, audit observations, and supplier quality issues.

Skills

Design Controls

Risk Management

Quality Systems

Good Documentation Practices

Analytical Skills

Technical Writing

Communication

Problem Solving

Cross-functional teamwork

Education

Bachelor's degree in Engineering or related technical discipline

Biomedical/Mechanical/Electrical Engineering (preferred)

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 new product development, design transfer, and post-market activities. The role partners with R&D, Operations, Regulatory Affairs, Clinical, and Marketing teams to ensure products are safe, effective, compliant, and meet customer needs.

The engineer will lead or support design change projects, maintain DHF documentation, and drive