Design Quality Engineer I

Boston Scientific•Marlborough, MA

1d•Hybrid

About The Position

The Design Quality Engineer I will support sustaining activities for Self Expanding Stents (SES) manufactured at the Galway site, as part of the Endoscopy Access and Patency franchise. The role develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet Boston Scientific, customer, and regulatory requirements. It serves as a Quality representative, helping improve awareness, visibility, and communication around quality initiatives in support of departmental, functional, site, divisional, and corporate quality goals and priorities. The position is part of the Endoscopy Division design site, which supports New Product Development, Sustaining Engineering, and Life Cycle Management initiatives. The role follows a hybrid work model, requiring employees to be in the local office at least three days per week. Approximately 10% travel is expected. Relocation assistance and visa sponsorship are not available.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related technical field.
Minimum of less than one year of experience.

Nice To Haves

Strong communication, collaboration, and documentation skills.
Internship, co-op, or project-based experience in engineering, quality, or medical devices.
Foundational understanding of design controls, risk management, and regulated product development.
Familiarity with basic statistical analysis tools; coursework in Minitab or Power BI is a plus.
Exposure to problem-solving methodologies such as DMAIC, 5 Whys, or other root-cause tools.

Responsibilities

Develop an understanding of Design Controls, Risk Management, and Usability for Medical Devices.
Provide quality and compliance input to cross-functional project teams, ensuring activities follow regulatory requirements and internal quality procedures.
Apply basic problem-solving tools, such as 5 Whys and Is/Is Not, with mentorship to support identifying, prioritizing, communicating, and resolving quality issues.
Contribute to ongoing improvements within quality and/or business processes by identifying opportunities to streamline documentation, processes, or tools.
Develop working relationships across departments and assist in communicating quality priorities and findings.
Support internal and external regulatory audits as required.
Provide quality and compliance input for post-market product-sustaining activities, including design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEPs, CAPAs, and Field Signals.