Senior Design Quality Engineer - Medical Devices (Hybrid)

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

Job summary

Boston Scientific in Marlborough, MA, seeks a Senior Design Quality Assurance Engineer to provide direct DQA support to a team tackling complex technical challenges across the Endoscopy portfolio, translating insights into product improvements.

You will lead Quality Deliverables, manage risk per ISO 14971, build strong cross-department relationships, and help establish best-in-class quality systems while mentoring others.

Qualifications

• BS in Biomedical Engineering, Mechanical Engineering or related degree.
• 5+ years medical device engineering experience.
• Strong knowledge of DMAIC and problem solving methodologies.
• Working knowledge of US and International medical device requirements (21 CFR 820, EU MDR, EN ISO 13485, EN ISO 14971).
• Travel approximately 10-20%.

Responsibilities

• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives using systematic approaches.
• Create and interpret data needed to make data driven decisions.
• Acts as the primary voice for quality within cross-functional teams, ensuring regulatory adherence.
• Lead the execution of Quality Deliverables (Project Design & Development Plan, Field Assessment Plan, Design Change Analysis, Design & Usability Validation Plans).
• Lead the Risk Management deliverables to ensure ISO 14971 compliance and patient safety.
• Establish strong cross-department relationships, communicating quality priorities and driving consensus.
• Identify and implement best-in-class practices for quality systems and processes.

Skills

DMAIC

Problem solving

Data-driven decisions

Cross-functional collaboration

Regulatory understanding

Education

Biomedical/Mechanical Eng degree

Tools

Minitab

Job description

Boston Scientific in Marlborough, MA, seeks a Senior Design Quality Assurance Engineer to provide direct DQA support to a team tackling complex technical challenges across the Endoscopy portfolio, translating insights into product improvements.

You will lead Quality Deliverables, manage risk per ISO 14971, build strong cross-department relationships, and help establish best-in-class quality systems while mentoring others.