Principal Software Design Quality Engineer - Axonics Integration

Boston Scientific Foundation Inc

Minnetonka, MN, US
Base: $102,100 - $194,000; bonus/equity: annual bo...
On-site
9 years design assurance experience
Software development life cycle knowledge
Iso 14971 risk management standards
This role supports a significant product development project with high visibility within the Urology division focusing on implantable and external devices

Job Summary

  • This role supports a significant product development project with high visibility within the Urology division focusing on implantable and external devices.
  • The position requires applying directives of design controls, software V&V, and risk management to ensure patient safety and regulatory compliance.
  • Boston Scientific offers relocation assistance for this hybrid role based in Minnetonka, MN, with a future transfer to Maple Grove in 2026.

Matching Summary

This role supports a significant product development project with high visibility within the Urology division focusing on implantable and external devices.

Salary

Base: $102,100 - $194,000; Bonus/Equity: Annual bonus target and long-term incentives available; Benefits: Core and optional employee benefits offered

Skills & Requirements

Must-have

  • 9 years design assurance experience
  • Software Development Life Cycle knowledge
  • ISO 14971 risk management standards
  • Software verification and validation expertise
  • Cross-functional team collaboration skills

Nice-to-have

  • Prior software design assurance background
  • Code review participation experience
  • Strong verbal and written communication
  • Adaptable to matrixed business environment
  • Cybersecurity risk analysis familiarity

Key Requirements

  • Bachelor's degree in engineering or related discipline
  • Minimum 9 years in medical device quality or design assurance
  • Understanding of IEC 62304 software standards
  • Experience with issue tracking and test management tools
  • US work authorization required (no sponsorship provided)

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter