Senior Design Quality Engineer - Medical Devices (Hybrid)

Boston Scientific; Marlboro (MA); On-site; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific in Marlborough, MA seeks a Senior Design Quality Assurance Engineer to lead cross-functional teams through complex problem solving and ensure regulatory compliance. You will drive design controls and risk management for the Endoscopy portfolio, delivering quality plans and validation activities.

This hybrid role requires on-site presence at least three days per week, with travel to support projects and a relocation option may be available.

Qualifications

• BS in Biomedical Engineering, Mechanical Engineering or related field.
• 5+ years of medical device engineering experience.
• Understanding of US & international medical device requirements (21 CFR 820, EU MDR, EN ISO 13485, EN ISO 14971).
• Proven problem-solving using DMAIC/Six Sigma methodologies.

Responsibilities

• Lead teams through complex problem-solving using DMAIC and Six Sigma.
• Create and interpret data to support data-driven decisions.
• Act as voice for quality in cross-functional teams and ensure regulatory compliance.
• Lead Design & Development Plans, Field Assessments, Design Change Analysis, and Usability Validation.
• Lead Risk Management deliverables to comply with ISO 14971 and ensure patient safety.
• Build relationships across departments and drive consensus on quality priorities.

Skills

DMAIC

Six Sigma

Minitab

Regulatory knowledge

Quality engineering

Design controls

Risk management

Leadership

Communication

Travel

Education

BS in Biomedical or Mechanical Engineering

Tools

Minitab

Job description

Boston Scientific in Marlborough, MA seeks a Senior Design Quality Assurance Engineer to lead cross-functional teams through complex problem solving and ensure regulatory compliance. You will drive design controls and risk management for the Endoscopy portfolio, delivering quality plans and validation activities.

This hybrid role requires on-site presence at least three days per week, with travel to support projects and a relocation option may be available.