Senior Design Quality Engineer - MedTech Innovation Leader

Boston Scientific; Marlborough (CT); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to support the Endoscopy portfolio. The role focuses on transforming technical insights into product improvements and portfolio value creation.

The position requires on-site presence in Marlborough, MA at least three days per week and offers relocation assistance. The candidate will work with cross-functional teams to ensure design controls and risk management meet regulatory standards.

Qualifications

• BS in Biomedical Engineering or related field.
• 5+ years of medical device engineering experience.
• Firm understanding of DMAIC and proven problem solving history.
• Knowledge of US and international medical device requirements including 21 CFR 820, EU MDR, EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Responsibilities

• Lead teams through complex problem-solving initiatives using structured methods (5 Whys, Is-Is Not, 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 compliance.
• Lead execution of Design & Development Plans, Field Assessment Plans, and Design Change Analyses.
• Lead Risk Management deliverables to ensure ISO 14971 compliance and patient safety.
• Communicate quality priorities across departments and drive consensus with stakeholders.
• Identify and implement best-in-class quality system improvements.

Skills

Medical device engineering

DMAIC problem solving

Root cause analysis

Quality mindset

Education

BS in Biomedical Engineering

Mechanical Engineering

Tools

Minitab

Six Sigma

Job description

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to support the Endoscopy portfolio. The role focuses on transforming technical insights into product improvements and portfolio value creation.

The position requires on-site presence in Marlborough, MA at least three days per week and offers relocation assistance. The candidate will work with cross-functional teams to ensure design controls and risk management meet regulatory standards.