Senior Design Quality Engineer - Cardiac Rhythm Diagnostics

Boston Scientific; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific Arden Hills, MN is seeking a Principal Design Quality Engineer to support active implantable medical devices. You will collaborate with R&D, process development, manufacturing and regulatory affairs to ensure safety, high quality, and regulatory compliance throughout the lifecycle.

This hybrid role requires in-office presence at least three days per week and offers relocation assistance not available.

Qualifications

• Bachelor’s degree in mechanical, electrical, or biomedical engineering.
• 9+ years in design assurance or related medical device industry.
• Ability to work in a mixed onsite + remote environment.
• Experience creating detailed technical documents.
• Experience with Design Controls and Risk Management.

Responsibilities

• Apply problem‑solving methodologies to identify and resolve quality issues.
• Support cross-functional teams in quality disciplines and decisions.
• Implement controls for new technology in complex medical devices.
• Write technical documentation for procedures and development records.
• Support Design Assurance activities related to Risk Management and Design Controls.
• Support post market activities using risk-based insights.
• Contribute to Design Change processes with thorough analyses.
• Apply validation and statistical techniques per standards.
• Assist verification, validation, and usability testing.
• Develop and maintain Design History File and related specifications.
• Create and maintain risk management tools (HA, FTA, FMEAs).
• Collaborate with R&D to implement Design Controls based on needs.
• Work cross-functionally to support value improvement.

Skills

Self-motivated

Quality tools/methodologies

Technical documentation

Cross-functional collaboration

Statistical methods

Education

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

Job description

Boston Scientific Arden Hills, MN is seeking a Principal Design Quality Engineer to support active implantable medical devices. You will collaborate with R&D, process development, manufacturing and regulatory affairs to ensure safety, high quality, and regulatory compliance throughout the lifecycle.

This hybrid role requires in-office presence at least three days per week and offers relocation assistance not available.