Business Analyst: AI Validation

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.
• Work closely with Quality Systems stakeholders, Data Scientists, Developers, Legal representatives, and Quality/Regulatory SMEs to ensure validation coverage and timely execution.
• Participate in cross-functional discussions to clarify requirements, test expectations, and validation outcomes.
• Ensure all validation activities are compliant with Boston Scientific software lifecycles, documentation standards, and applicable regulatory expectations.
• Support audit readiness by maintaining accurate, complete, and defensible validation packages.
• Identify opportunities to improve validation templates, documentation clarity, and lifecycle execution, and share input with governance leads.
• Assist in developing standardized test cases and documentation patterns to improve efficiency and consistency across AI validation projects.
• Organize and track validation activities to support timely delivery of milestones.
• Manage concurrent validation tasks across multiple AI tools, providing updates to project managers as needed.

Qualifications:

Required qualifications:

• Minimum of 5 years' experience in software validation, quality engineering, or validation roles in a regulated environment (medical device, pharma, biotech, or equivalent).
• Strong knowledge of validation documentation practices including requirements traceability, intended use, test case development, and change control.
• Demonstrated experience executing validation testing and preparing audit-ready documentation.
• Ability to interpret user workflows and translate them into testable requirements.
• Excellent documentation skills with strong attention to detail and compliance focus.
• Ability to collaborate effectively with Data Scientists, developers, Quality/Regulatory SMEs, and process owners.
• Strong analytical and problem-solving skills with the ability to identify and escalate documentation or testing gaps.
• Comfortable managing multiple validation tasks in parallel projects.
• Experience following structured validation lifecycles, SOPs, and WI-driven processes.
• Strong communication skills with the ability to explain test outcomes and documentation gaps clearly and concisely.
• Ability to work independently within defined governance and validation frameworks.

Preferred qualifications:

• Familiarity with AI/ML-enabled tools, automated systems, or algorithmic platforms (training can be provided).
• Experience with Gen AI lifecycle, GSM, or similar validation models.
• Understanding of Quality and Regulatory workflows in the medical device or life sciences industry.

Requisition ID: 623497

The anticipated annualized base amount or range for this full time position will be $ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.