Senior Design Quality Engineer - Endoscopy

Boston Scientific•Georgetown, MA

8d•$89,200 - $169,500•Hybrid

About The Position

The Senior Design Quality Assurance Engineer will provide direct DQA support to a team focused on solving complex technical challenges across the Endoscopy portfolio and transforming technical insights into meaningful product improvements, design enhancements, and portfolio value creation. The position is part team that will engage in the most critical and complex issues impacting performance across the portfolio. Through that work, they will enable the longer-term objective of building a robust pipeline of iterative innovations, design improvements, and market-facing product enhancements.

Requirements

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%.

Nice To Haves

8+ years of medical device engineering experience.
Proficiency in Minitab Statistical Analysis software or equivalent.
Six Sigma Certification.
Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
Excellent communication, presentation, and interpersonal skills, with the ability to influence teams and leadership.
Proven ability to lead and coach others, driving a high-performance quality culture.
Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.

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. Uses influence and negotiation skills to integrate quality perspectives into business decisions.
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.