Senior Design Quality Engineer – Medical Devices

Boston Scientific; Marlborough (MA); Ibrido; USD 89.000 - 170.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• BS in Biomedical Engineering, Mechanical Engineering or related degree.

Mansioni

• 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.

Conoscenze

Medical device engineering

DMAIC / Six Sigma

Regulatory knowledge 21 CFR 820 / EU-M

Root cause analysis

Cross-functional collaboration

Formazione

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Strumenti

Minitab

Descrizione del lavoro

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.