Boston Scientific is a global medical technology company developing innovative devices and therapies that improve patient health. The Design Assurance Engineer I supports medical device product development from concept through commercialization by ensuring safety, quality, and compliance. The role focuses on risk management, test method development, design verification and validation, regulatory assessments, and quality documentation.
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 (i.e., 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)
Qualification
Required
Bachelor's degree in Biomedical Engineering
Previous internship experience with Boston Scientific
Must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization
3 months experience in Design Quality Assurance at a medical device company
Preferred
Focus on detailed work with emphasis on accuracy and completeness
Excellent organizational and planning skills; drives for results
Strong communication (oral and written) and presentation skills
Design verification experience
Risk management for medical device (ISO 14971)
Benefits
Access to the latest tools, information and training
Support in progressing and advancing skills and career
On-site work model, requiring employees to be in the local office at least four days per week
Annual bonus target for eligible non-exempt, non-sales roles, subject to plan eligibility and other requirements
Annual bonus target and long-term incentives for eligible exempt, non-sales roles, subject to plan eligibility and other requirements
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
