Senior Quality Engineer - Cardiac Diagnostics (CDx) at Boston Scientific

Department: Engineering

Compensation

$85,000 – $161,500/yr

Setup: On-site
Location: Arden Hills, Minnesota
Type: Full-time
Level: senior
Posted: Sep 18, 2026

Description

Boston Scientific is hiring a Senior Quality Engineer for its Cardiac Diagnostics business to lead quality initiatives, CAPA processes, root-cause investigations, process validation, defect analysis, regulatory submissions, and compliance activities. The role requires a bachelor’s degree in engineering or a related discipline, at least five years of relevant quality engineering experience, and knowledge of medical device regulations and ISO 13485. The listed salary range is $85,000 to $161,500, with compensation varying by location and experience.

Required Skills

CAPA
ISO 13485
Risk Management
Defect Analysis
Medical Devices
Windchill
Validation

Additional Information

Minimum Education: Bachelor’s degree in engineering or a related discipline
Required Previous Experiences: 5+ years of relevant quality engineering experience
CAPA experience leading root-cause investigations and corrective-action verification
Medical device industry experience
Preferred Qualifications: Experience with software and hardware development, manufacturing engineering, post-market complaints, risk management, supplier quality, and process engineering
Experience with Microsoft Office and Windchill PLM
2+ years of validation, statistical sampling, or root-cause investigation experience
Familiarity with QMS documentation, including DHF, DMR, DHR, SOPs, WIs, and FMEAs
Problem-solving certification such as CQE or Six Sigma
Program or project management skills
Critical thinking, active listening, and time management
Ability to quickly learn new processes
Analytical and communication skills