Clinical Software Quality Manager

Boston Scientific Foundation Inc

Arden Hills, MN, US
Base: $82,100 - $156,000; bonus/equity: annual bon...
On-site
Software quality and validation
Clinical software oversight
Vendor assessment and qualification
The Clinical Software Manager serves as the Quality representative to the Clinical organization, providing strategic guidance on software systems and data governance across all phases of clinical development

Job Summary

  • The Clinical Software Manager serves as the Quality representative to the Clinical organization, providing strategic guidance on software systems and data governance across all phases of clinical development.
  • This role oversees the team members who perform assessment, qualification, and audit clinical, software, and pre-clinical vendors to ensure alignment with global regulatory requirements and internal quality standards.
  • Boston Scientific is committed to solving the challenges that matter most – united by a deep caring for human life, advancing science for life through innovative medical solutions.

Matching Summary

The Clinical Software Manager serves as the Quality representative to the Clinical organization, providing strategic guidance on software systems and data governance across all phases of clinical development.

Salary

Base: $82100 - $156000; Bonus/Equity: Annual bonus target and long-term incentives; Benefits: Core and optional employee benefits

Skills & Requirements

Must-have

  • software quality and validation
  • clinical software oversight
  • vendor assessment and qualification
  • risk-based vendor oversight
  • regulatory compliance
  • cross-functional team leadership

Nice-to-have

  • executive presence and influence
  • deep clinical knowledge
  • digital health technologies
  • Real-World Data environments
  • continuous improvement culture

Key Requirements

  • Bachelor's degree in computer science, engineering, life sciences, or related field
  • 5 years' experience in software quality, validation, audit, or quality systems
  • 3 years' experience in a managerial or leadership role
  • Proven background in ISO 13485, IEC 60601, FDA guidelines, ISO 14155, and 21 CFR Part 11

Work Rights

Not specified

Tailored Resume

Cover Letter