Design Quality Engineer II: Interventional Cardiology (Hybrid)

Boston Scientific; Maple Grove (MN); Hybrid; USD 72,000 - 136,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific is seeking a Design Quality Engineer II for Interventional Cardiology at the Arbor Lakes campus in Maple Grove, MN. The role focuses on design controls, risk management, and verification/validation of capital equipment for medical electrical systems.

Hybrid work arrangement requiring onsite presence at least three days per week, with relocation assistance possible. This position emphasizes patient safety, quality processes, and cross-functional teamwork in a regulated

Qualifications

• Bachelor of Science degree in engineering or related field.
• 2+ years of experience in an engineering role within medical device or similar regulated industry.
• Knowledge of Quality System Requirements, Good Documentation Practices, and relevant standards and regulations (e.g., ISO 13485, ISO 14971).
• Comfortable working independently and as part of a cross-functional team.
• Collaborative mindset and willingness to learn in a team-oriented environment.
• Strong written and verbal communication skills.

Responsibilities

• Develop, update, and maintain Design History File and Design Input / Output documentation (e.g., Product Specification, Component Specifications, and Prints)
• Develop, update, and maintain product Risk Management documentation (e.g., Hazard Analysis, Fault Tree, FMEAs)
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements
• Work within a cross-functional team to identify and implement effective controls and support new product and commercial design changes, specifically with regard to quality and risk management
• Apply sound, systematic problem-solving methodologies to resolve quality issues
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs
• Apply basic problem-solving techniques to identify, communicate, and resolve quality issues
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Skills

Quality systems knowledge

Cross-functional collaboration

Communication skills

Independent worker

Education

Bachelor of Science in Engineering

Tools

DFMEA

Hazard Analysis

Root Cause Analysis

Design Controls

Quality Documentation

Job description

Boston Scientific is seeking a Design Quality Engineer II for Interventional Cardiology at the Arbor Lakes campus in Maple Grove, MN. The role focuses on design controls, risk management, and verification/validation of capital equipment for medical electrical systems.

Hybrid work arrangement requiring onsite presence at least three days per week, with relocation assistance possible. This position emphasizes patient safety, quality processes, and cross-functional teamwork in a regulated