Senior Design Quality Engineer

This job is with Boston Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About this role:

The Senior Design Quality Assurance Engineer directly supports medical device product development from after commercialization while serving as a key leader in the CAPA process. This individual partners with high-performing cross-functional development teams to ensure the safety, quality, and compliance of our products, driving effective resolution of design-related issues and continuously improving commercial value.

This position is part of the design site for the Endoscopy Division and supports New Product Development, Sustaining Engineering, Life Cycle Management, and Quality System initiatives related to design and development, including the execution and oversight of design-impacting CAPAs.

This is a hybrid position based out of Marlborough, MA with a minimum of three days per week onsite.
Your responsibilities include:
Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices.
Leads the end-to-end execution of the NCEP/CAPA process, ensuring timely investigation, root cause analysis, action implementation, and effectiveness verification in accordance with FDA, ISO 13485, and internal Quality System requirements.
Oversees CAPA portfolio management, ensuring appropriate prioritization, resource allocation, and escalation to leadership for high-risk or system-level issues.
May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources.  Acts as division representative on cross-divisional projects defining the quality system(s).
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.
Guides and mentors engineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
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.

Required Qualifications:

Minimum of a Bachelors degree  Biomedical Engineering, Mechanical Engineering or related degree.
Minimum of 5 years of medical device engineering experience.
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.
Strong technical expertise in CAPA management, including root cause analysis, effectiveness verification, and implementation of sustainable corrective and preventive actions within a regulated medical device Quality System.
Travel approximately 10-20%.

Preferred Qualifications:

6+ 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,…