Senior Design Assurance Lead, Field CAPA & Cross-Functional

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

Job summary

Boston Scientific is seeking a Principal Design Assurance Engineer for Field CAPA (CRMDx) in Arden Hills, MN. The role leads cross‑functional teams to investigate product performance issues (NCEPs, PIRs, CAPAs) and to implement effective CAPA solutions, partnering with R&D, Regulatory, Manufacturing and quality organizations.

The position emphasizes leadership, complex problem‑solving, and project management, with on‑site work at least three days per week and relocation support not offered at

Qualifications

• Bachelor's degree in engineering or related field with 8+ years of experience, or MS with 6+ years.
• Experience with Quality System Regulations, Medical Device Regulation, and ISO13485.
• Experience in Medical Device industry.

Responsibilities

• Leads cross‑functional teams on complex product performance investigations (NCEPs, PIRs, CAPAs).
• Facilitates high-performing teams toward goals and timelines.
• Uses disciplined problem-solving techniques (DMAIC, 5 Whys, cause & effect).
• Maintains documentation per Good Documentation Practice.
• Represents NCEPs, PIRs, CAPAs in audits.
• Mentors cross‑functional teams in NCEPs, CAPAs, PIRs.
• Engages in Global Communities of Practice for improvement.
• Ensures compliance with Quality Policy and procedures.

Skills

NCEPs

CAPAs

PIRs

Root Cause Analysis

DMAIC

5 Whys

Cause & Effect Diagram

Statistics

Microsoft Office

MINITAB

Weibull++

Communication

Leadership

Project Management

Education

Bachelor's or MS in engineering

Tools

MINITAB

Weibull++

Microsoft Office

Job description

Boston Scientific is seeking a Principal Design Assurance Engineer for Field CAPA (CRMDx) in Arden Hills, MN. The role leads cross‑functional teams to investigate product performance issues (NCEPs, PIRs, CAPAs) and to implement effective CAPA solutions, partnering with R&D, Regulatory, Manufacturing and quality organizations.

The position emphasizes leadership, complex problem‑solving, and project management, with on‑site work at least three days per week and relocation support not offered at