Senior Design Quality Engineer - Endoscopy
Boston Scientific
Summary
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.
Job description
Your responsibilities include:
- 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.
What we're looking for in you:
Required 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%.
Preferred Qualifications
- 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.
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%
- 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
Benefits
- Relocation assistance
- Annual bonus target
- Long-term incentives
Company overview
Boston Scientific Corporation is a global leader in the development, manufacturing, and marketing of minimally invasive medical devices used in interventional medical specialties. Founded in 1979 and headquartered in Marlborough, Massachusetts, the company focuses on transforming patient lives through innovative medical solutions across a wide range of therapeutic areas including cardiology, endoscopy, urology, pulmonology, and neuromodulation. With approximately 53,000 employees worldwide and operations in 40 countries, Boston Scientific serves over 44 million patients annually. The company invests heavily in research and development, allocating $1.6 billion to R&D in 2024, and maintains a strong commitment to quality, patient safety, and meaningful innovation. Boston Scientific's product portfolio includes advanced technologies such as cardiac rhythm management devices, coronary stents, ablation systems, endoscopy equipment, and neuromodulation therapies, all designed to improve patient outcomes and quality of life through less invasive treatment options.