Design Assurance Engineer I - Medical Devices

Boston Scientific; Maple Grove (MN); On-site; USD 60,000 - 114,000; Full time

Job summary

Boston Scientific is seeking a Design Assurance Engineer I to join our on-site team in Minnesota. You will support medical device product development from concept to commercialization, focusing on risk management, test method development, and design verification planning/testing.

You will work with cross-functional teams to ensure safety, quality, and regulatory compliance, contributing to Design Controls, Risk Management, and Usability activities throughout the product lifecycle.

Qualifications

• Bachelor’s degree in Biomedical Engineering.
• Previous internship experience with Boston Scientific.
• Eligible to work in the U.S. without sponsorship now or in the future.
• 3 months experience in Design Quality Assurance at a medical device company.
• Strong communication and presentation skills; detail-oriented and organized.

Responsibilities

• Actively promote and participate in a cross-functional teamwork environment.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Provide quality and compliance input to project teams for project decisions and deliverables (Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Successfully complete engineering work in one or more of the following: test method validation, risk management, bench and verification testing.
• Support development and coordinate the execution of Design Validation and Verification activities.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
• Perform regulatory standard assessments and support regulatory submissions to notified bodies.
• Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

Skills

Design Quality Assurance

Test Method Validation

Risk Management

Usability Testing

Design Verification

Documentation

Cross-Functional Collaboration

Communication Skills

Education

Bachelor's degree in Biomedical Engineering

Job description

Boston Scientific is seeking a Design Assurance Engineer I to join our on-site team in Minnesota. You will support medical device product development from concept to commercialization, focusing on risk management, test method development, and design verification planning/testing.

You will work with cross-functional teams to ensure safety, quality, and regulatory compliance, contributing to Design Controls, Risk Management, and Usability activities throughout the product lifecycle.