Entry-Level Design Assurance Engineer – Medical Devices

Socket.dev; Maple Grove (MN); On-site; USD 60,000 - 114,000; Full time

Job summary

Boston Scientific is seeking a Design Assurance Engineer I to support medical device development from concept to commercialization. You will work with cross-functional teams to ensure safety, quality, and compliance throughout new product development, focusing on risk management, test methods, and D&V planning.

The role requires a BS in Biomedical Engineering, internship experience with Boston Scientific, and US work authorization.

Qualifications

• Bachelor’s degree in Biomedical Engineering.
• Must be eligible to work in the U.S. without sponsorship.
• 3 months experience in Design Quality Assurance at a medical device company.
• Internship experience with Boston Scientific.

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).

Education

Bachelor’s degree in Biomedical Engineering

Job description

Boston Scientific is seeking a Design Assurance Engineer I to support medical device development from concept to commercialization. You will work with cross-functional teams to ensure safety, quality, and compliance throughout new product development, focusing on risk management, test methods, and D&V planning.

The role requires a BS in Biomedical Engineering, internship experience with Boston Scientific, and US work authorization.