Principal Design QA Engineer – Medical Devices & Compliance

Boston Scientific; Marlborough (MA); Hybrid; USD 97,000 - 184,300; Full time

Job summary

Boston Scientific is seeking a Principal Design Quality Assurance Engineer for the Endoscopy Division in Marlborough, MA. This hybrid on-site role requires 3 days/week on-site, with relocation assistance possibly available.

You will drive quality deliverables, oversee regulatory compliance, and mentor teams to ensure patient safety and continuous improvement. The role covers design development, life cycle management, and quality systems initiatives, with travel 10–20% and a strong emphasis on

Qualifications

• BS in BiomedicalEngineering, MechanicalEngineering or related degree.
• 8+ years of medical device engineering experience.
• Knowledge of US and international medical device requirements including 21 CFR 820, MDD/MDR, EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Responsibilities

• Act as the primary voice for quality within cross-functional teams, influencing project direction and ensuring regulatory compliance.
• Lead the execution of Quality Deliverables (Design & Development Plan, Field Assessment Plan, Design Change, Usability Validation Plans) and Risk Management deliverables per ISO 14971.
• Interface with senior management on significant matters and coordinate activity across organizational units.
• Apply systematic problem-solving approaches (e.g., 5 Whys, DMAIC, Six Sigma) to diagnose root causes and optimize processes.
• Mentor engineers and foster a culture of learning and technical excellence.

Skills

Quality engineering

Regulatory requirements

Project leadership

Root cause analysis

Process improvement

Cross-functional collaboration

Mentoring

Quality systems

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Tools

Minitab

Six Sigma Black Belt

Job description

Boston Scientific is seeking a Principal Design Quality Assurance Engineer for the Endoscopy Division in Marlborough, MA. This hybrid on-site role requires 3 days/week on-site, with relocation assistance possibly available.

You will drive quality deliverables, oversee regulatory compliance, and mentor teams to ensure patient safety and continuous improvement. The role covers design development, life cycle management, and quality systems initiatives, with travel 10–20% and a strong emphasis on