Design Quality Engineer III - Interventional Cardiology

Boston Scientific•Maple Grove, MN

2d•$78,300 - $148,800•Hybrid

About The Position

Boston Scientific is currently recruiting for a Sustaining Design Quality Engineer III in our Arbor Lakes, MN location. This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC. The Design Quality Engineer III will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires being on-site at least three (3) days per week.

Requirements

Bachelor’s degree in an engineering discipline
Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
Knowledge of basic Quality System Requirements and Good Documentation Practices

Nice To Haves

Bachelor’s degree in mechanical, electrical, or biomedical engineering
Experience with design control, risk management, and medical device standards compliance
Experience with corrective and preventive action
Adaptable and effective collaborator in a team environment and in self-directed work
Strong communication skills (verbal & written)

Responsibilities

Ownership of design change projects including scoping, assessment, and implementation.
Develop, update, and maintain Design History File and Design Input / Output documentation
Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.