Design Quality Assurance Engineer III - Endoscopy

Boston Scientific • Georgetown, MA

3d • $82,100 - $156,000 • Hybrid

About The Position

The Design Quality Assurance Engineer III leads complex design-related nonconformance (NCEP) and CAPA activities across the product lifecycle. The role works with a cross-functional development team to ensure product safety, quality, and regulatory compliance while supporting continuous improvement of commercial value.

Based at the Endoscopy Division design site, the position supports NCEP/CAPA activities, quality process improvements, and quality systems initiatives related to design and development. It is a hybrid role based in Marlborough, Massachusetts, requiring onsite work at least three days per week. Travel is approximately 10–20%. Relocation assistance and employment visa sponsorship are not available.

The role provides quality oversight and guidance for investigations, corrective and preventive actions, design controls, project deliverables, quality-system improvements, and regulatory audits. It also mentors engineers and represents the quality perspective on cross-functional teams.

Requirements

• Bachelor of Science degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• At least 3 years of medical device engineering experience.
• Detailed understanding and working knowledge of US and international medical device requirements, including 21 CFR Part 820, the Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485, and EN ISO 14971.
• Proven experience leading and owning CAPAs in a design environment.
• Proficiency in root cause analysis tools and methodologies.
• Willingness to travel approximately 10–20%.

Nice To Haves

• 5 or more 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 and promote a high-performance quality culture.
• Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.

Responsibilities

• Lead and provide quality oversight for complex design-related NCEP/CAPA activities, ensuring timely progression and compliance with regulatory and Quality System requirements.
• Lead teams through complex investigations and problem-solving, applying methods such as 5 Whys, Is-Is Not, DMAIC, and Six Sigma to identify root causes and ensure sustained corrective actions.
• Partner with cross-functional teams to develop risk-appropriate corrective and preventive actions that address identified causes and support sustainable solutions.
• Provide quality and compliance input to project teams on design control decisions and deliverables, including Design Change Analysis, Design Inputs and Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation, and Labeling.
• Guide and mentor engineers, including coaching on quality engineering methods and problem-solving techniques.
• Represent quality on cross-functional teams, influence project direction, and ensure adherence to regulatory requirements, internal procedures, and quality practices.
• Identify and implement best-in-class departmental practices and assess opportunities to improve quality systems and processes.
• Support internal and external regulatory audits as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior