Hybrid Sustaining Design Quality Engineer III

Boston Scientific; Maple Grove (MN); Hybrid; USD 78,000 - 149,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific is recruiting for a Sustaining Design Quality Engineer III at the Arbor Lakes, MN location. You will contribute to quality assurance of medical electrical equipment within Interventional Cardiology, collaborating with a high-performance cross-functional team to ensure safety, quality and regulatory compliance across design changes.

The role is hybrid, requiring on-site presence at least three days per week, with relocation assistance possibly available and no visa sponsorship.

Qualifications

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

Responsibilities

• Own design change projects from scoping to implementation.
• Develop, update, and maintain Design History File and Design Input/Output documentation.
• Update and maintain risk management files (Hazard Analysis, Task Analysis, Design FMEA).
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports.
• Provide design quality support for PIRs, CAPAs, and NCEPs.
• Apply systematic problem-solving to identify and resolve quality issues.
• Commit to patient safety and product quality by following quality policies and procedures.

Skills

Design assurance

Quality systems

Regulatory compliance

Communication skills

Education

Bachelor’s degree in engineering

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

Tools

Design History File

Job description

Boston Scientific is recruiting for a Sustaining Design Quality Engineer III at the Arbor Lakes, MN location. You will contribute to quality assurance of medical electrical equipment within Interventional Cardiology, collaborating with a high-performance cross-functional team to ensure safety, quality and regulatory compliance across design changes.

The role is hybrid, requiring on-site presence at least three days per week, with relocation assistance possibly available and no visa sponsorship.