Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role:
This is a hands-on validation execution role focused on documentation, testing, and compliance alignment for AI-enabled Quality and Regulatory tools. The position supports validation activities by preparing documentation, executing testing, managing traceability and change control, and coordinating cross-functional inputs to ensure alignment with applicable software lifecycles and Boston Scientific Quality System requirements.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your responsibilities will include:
- Draft validation documentation such as Intended Use statements, GSMA content, test plans, and test scripts based on governance guidance and lifecycle expectations.
- Execute validation testing according to the applicable lifecycle (e.g., Gen AI lifecycle, GSM), including evidence capture, defect logging, and result documentation.
- Maintain complete traceability across requirements, intended use, test cases, and outputs.
- Support preparation and routing of change-control documentation associated with validation deliverables.
- Collaborate with Quality and Regulatory process owners, SMEs, and end users to understand workflow needs and translate them into testable requirements.
- Incorporate user feedback into validation documentation and testing refinements.
- Identify ambiguities or gaps in requirements and escalate to governance leads for clarification.
- Coordinate validation readiness activities such as access, test data preparation, environment setup, and scheduling.