Design Quality Engineer I – Hybrid Medical Devices

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

Job summary

Boston Scientific is seeking a Design Quality Engineer I to join the Endoscopy Access and Patency franchise. This role supports sustaining for Self Expanding Stents and develops, establishes and maintains quality engineering methodologies to meet regulatory and customer requirements.

You will act as a Quality representative to improve awareness and drive quality initiatives across teams. The position offers a hybrid work model in the Marlborough, MA area and requires a Bachelor's degree in

Qualifications

• Foundational knowledge of design controls and risk management.
• Exposure to design validation and usability engineering.

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

Strong communication

Collaboration

Documentation

Problem-solving

Education

Bachelor's degree in Biomedical or Mechanical Engineering

Tools

Minitab

PowerBI

Job description

Boston Scientific is seeking a Design Quality Engineer I to join the Endoscopy Access and Patency franchise. This role supports sustaining for Self Expanding Stents and develops, establishes and maintains quality engineering methodologies to meet regulatory and customer requirements.

You will act as a Quality representative to improve awareness and drive quality initiatives across teams. The position offers a hybrid work model in the Marlborough, MA area and requires a Bachelor's degree in