Design Quality Engineer I – Medical Devices

Boston Scientific; Marlboro (MA); Hybrid; USD 63,000 - 119,000; Full time

Job summary

Boston Scientific Marlboro, MA is seeking a Design Quality Engineer I to support the Endoscopy Access and Patency franchise, focusing on SES from the Galway site. The role develops quality engineering methods to meet regulatory and customer requirements.

The position is part of the design site for the Endoscopy Division, supporting New Product Development, Sustaining Engineering, and Life Cycle Management. Hybrid work requires in-office presence three days per week.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related technical field.
• Less than one year of experience.
• Travel approximately 10%.

Responsibilities

• Develop 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.

Skills

Communication

Collaboration

Documentation

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Tools

Minitab

PowerBI

Job description

Boston Scientific Marlboro, MA is seeking a Design Quality Engineer I to support the Endoscopy Access and Patency franchise, focusing on SES from the Galway site. The role develops quality engineering methods to meet regulatory and customer requirements.

The position is part of the design site for the Endoscopy Division, supporting New Product Development, Sustaining Engineering, and Life Cycle Management. Hybrid work requires in-office presence three days per week.