Senior Medical Device Quality Engineer (Design & Risk)

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

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific in Marlborough, MA is seeking a Senior Design Quality Assurance Engineer to support the Endoscopy portfolio, turning technical insights into product improvements and portfolio value.

The role engages in complex issues across the portfolio, enabling a pipeline of innovations, design improvements and market-facing enhancements. The position is hybrid, based in Marlborough and requires on-site presence at least three days per week.

Qualifications

• BS in Biomedical Engineering, Mechanical Engineering or related degree.
• 5+ years of medical device engineering experience.
• Firm understanding of DMAIC system and proven history of problem solving
• Detailed understanding and working knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Responsibilities

• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
• Create and interpret data needed to make the best data driven decisions possible.
• Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices.
• Lead the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change Analysis, and Design & Usability Validation Plans.
• Leads the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
• Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders.
• Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.

Skills

DMAIC

Root cause

Regulatory know-how

Quality tools

Education

Biomedical/Mechanical Eng

Tools

Minitab

Job description

Boston Scientific in Marlborough, MA is seeking a Senior Design Quality Assurance Engineer to support the Endoscopy portfolio, turning technical insights into product improvements and portfolio value.

The role engages in complex issues across the portfolio, enabling a pipeline of innovations, design improvements and market-facing enhancements. The position is hybrid, based in Marlborough and requires on-site presence at least three days per week.