Senior Design Quality Engineer - Cardiac Rhythm Management & Diagnostics; CRMDx

Additional Location(s): N/ADiversity
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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.

About the role:

This Senior Design Quality Engineer position will support active implantable medical devices. This position will serve as a quality representative on product development projects and will collaborate with cross functional teams including R&D, process development, manufacturing, and regulatory affairs to help ensure that the product and processes remain safe, of high quality, and compliant with BSC and regulatory requirements throughout the product lifecycle process.

Work Mode:

Boston Scientific values collaboration, and this hybrid role requires employees to work from the Arden Hills, MN office at least three days per week.

Relocation Assistance:

Relocation assistance is not available for this position.

Visa Sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Your responsibilities will include:

Owns and drives deliverables related to Risk Management, Design Controls, Product Performance, Quality, and Compliance.

Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Acts as an effective team member in supporting quality disciplines, decisions, and practices.

Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices.

Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.

Develops and implements quality strategies; seeks innovative approaches to attain quality goals.

Support Post Market activities, as necessary, of risk based on post-market signals.

Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.

Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.

Support the verification, validation, and usability testing to meet or exceed internal and external requirements.

Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

Partner cross-functionally to identify and support value improvement efforts to support business goals.

Directly interfaces with internal and external audit activities.

What we’re looking for in you:

Required qualifications:

Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).5+ years of experience in design assurance, new product development or related medical device / regulated industry experience.

Self-motivated with a passion for solving problems and a bias for action.

Strong communication skills (verbal & written). Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.

Demonstrated use of…