Senior Design Quality Engineer, Medical Devices

Socket.dev

South Carolina

On-site

USD 89,000 - 170,000

Full time

6 days ago

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Benefits offered by this job

Relocation assistance

On-site in MA

Job summary

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to support the Endoscopy portfolio, turning technical insights into product improvements and market-ready enhancements. The role is part of a team tackling the most critical issues affecting portfolio performance and requires up-to-date knowledge of quality systems and regulatory requirements.

Based in Marlborough, MA, the hybrid role requires on-site presence at least three days per week.

Qualifications

BS in Biomedical Engineering, Mechanical Engineering or related degree.
5+ years of medical device engineering experience.
Strong understanding of DMAIC and proven problem-solving history.
Knowledge of US and International medical device requirements (21 CFR 820, MDD/MDR, EN ISO 13485, EN ISO 14971).
Travel approximately 10-20%.

Responsibilities

Lead teams through complex problem-solving using rigorous methodologies (DMAIC, Six Sigma).
Create and interpret data to support data-driven decisions.
Act as the primary voice for quality within cross-functional teams and ensure regulatory adherence.
Lead the execution of Quality Deliverables (PDP/Development Plan, Field Assessment, Design Change Analysis, Usability Validation).
Lead Risk Management deliverables to ensure ISO 14971 compliance and patient safety.
Communicate quality priorities across departments and influence business decisions.