Design Quality Engineer I

Boston Scientific • Georgetown, MA

2d • $62,800 - $119,300 • Hybrid

About The Position

The Design Quality Engineer I will be part of the Endoscopy Access and Patency franchise supporting sustaining for Self Expanding Stents (SES) manufactured at the Galway site. The Design Quality Engineer I will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. This engineer will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. This position is part of the design site for the Endoscopy Division which supports New Product Development, Sustaining Engineering, and Life Cycle Management initiatives.

Requirements

• Minimum of a Bachelors degree in Biomedical Engineering, Mechanical Engineering, or related technical field.
• Minimum of less than one year of experience.
• Travel approximately 10%

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 PowerBI 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 (e.g., 5 Whys, 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, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s and Field Signals.

Benefits

• Relocation assistance is not available for this position at this time.
• Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

What This Job Offers

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