Design Assurance Engineer

Additional Location(s): N/ADiversity
- Innovation
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- High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Design Assurance Engineer IWe will consider qualified applicants of all ages who are starting (or restarting) their careers

At Boston Scientific, we value collaboration and synergy. This role follows an on-site work model, requiring employees to be in our local office at least four days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time

About the role:

The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional team to ensure safety, quality and compliance throughout new product development. This position will focus on establishing robust risk management, test method development, and design verification planning/testing through the new product development process

Your responsibilities will include:

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).

Required Qualifications:

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 authorization3 months experience in Design Quality Assurance at a medical device company

Preferred Qualifications:

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)

Requisition  Salary: $ 59900

Maximum Salary: $ 113800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see —will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education…