Senior Design Quality Engineer – Medical Devices

Boston Scientific

Marlborough (MA)

Hybrid

USD 89,000 - 170,000

Full time

6 days ago

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Job summary

Boston Scientific in Marlborough, MA is seeking a Senior Design Quality Assurance Engineer to provide direct DQA support for the Endoscopy portfolio, translating complex technical insights into meaningful product improvements and portfolio value creation. The role supports a team addressing critical issues across the portfolio to build a robust pipeline of innovations.

This hybrid position requires on-site presence at least three days per week and relocation assistance may be available.

Qualifications

BS in Biomedical Engineering, Mechanical Engineering or related degree.

Responsibilities

Lead teams through complex problem-solving initiatives using DMAIC, Six Sigma, and root-cause analysis.
Create and interpret data to enable data-driven decisions.
Be the primary quality voice in cross-functional teams and ensure regulatory compliance.
Lead the execution of Project Design & Development, Field Assessment, Design Change Analysis, and Usability Validation plans.
Lead Risk Management deliverables to ensure ISO 14971 compliance and patient safety.
Establish strong relationships across departments and drive consensus on quality priorities.
Identify opportunities to improve quality systems and processes.