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Boston Scientific · 1 week ago

Design Quality Engineer III - Interventional Cardiology

Maple Grove, MN

Full-time

Hybrid

Mid Level

$76K/yr - $144K/yr

3+ years exp

Boston Scientific is a leader in medical science dedicated to solving health industry challenges. The Design Quality Engineer III will participate in the quality assurance of single-use devices within the Interventional Cardiology division, supporting design controls and ensuring the safety, quality, and compliance of products.

Health CareMedicalMedical Device

No H1B

Responsibilities

Identify and implement effective controls to support development or maintenance of products to meet internal and external requirements

Develop, update, and maintain Design History File and Design Input / Output documentation

Develop, 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

Qualification

Design AssuranceQuality ToolsMedical Device StandardsRisk ManagementTechnical ReportsCommunicationProblem SolvingCollaboration

Required

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

Experience writing specifications, test protocols, and technical reports

Demonstrated use of quality tools and methodologies include DFMEA, Hazard Analysis, Root Cause Analysis

Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics

Strong communication skills (verbal and written). Effectively present complicated technical information to small and large audiences, from peers to senior leadership

Preferred

Bachelor's degree in mechanical, electrical, or biomedical engineering

Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization

Experience in design engineering or process development, including design optimization and process validation

Adaptable and effective collaborator in a team environment and in self-directed work