Specialist Business Analyst

Payrate: $43.00 - $44.00/hr

The Specialist Business Systems Analyst will be a key member of the programming team working towards the implementation of Product Lifecycle Management (PLM). As a part of this cross-functional team within the Combination Product Operations (CPO) organization, you would assist with the deployment of the 3

DEXPERIENCE PLM platform from Dassault Systems, that will help digitize combination product design, development, and technology transfer to company’s manufacturing network. The CPO Digital team is one of a network of digital teams focused on implementing state-of-the-art digital capabilities transforming the business by improving efficiency and speed, while reducing the cost of developing, manufacturing, and distributing combination products to our stakeholders and patients.

• Generate reports and communicate insights to both technical and non-technical stakeholders.
• Document, assess, and analyze current-state business processes associated with FDA 21 CFR 820.30 design controls, including design inputs, risk management, design outputs, workflow execution, and end-to-end traceability, to identify gaps, optimize processes, and drive continuous improvement initiatives.
• Build and maintain a network of business and technical Subject Matter Experts (SMEs) to understand stakeholder needs, identify pain points, and drive alignment on process transformation initiatives.
• Facilitate workshops, interviews, and working sessions to elicit, analyze, and document business requirements, business rules, and future-state process designs.
• Translate business needs into clear user stories, functional requirements, process flows, acceptance criteria, and other delivery-ready artifacts.
• Create, prioritize, refine, and maintain a stack-ranked product backlog for one or more Agile product teams, ensuring alignment with business value and strategic objectives.
• Partner with Product Owners, Solution Architects, Developers, and SMEs to design solutions and provide ongoing requirements clarification throughout the development lifecycle.
• Support solution delivery by validating requirements, developing test scenarios, coordinating User Acceptance Testing (UAT), and managing defect resolution activities.
• Collaborate with stakeholders to ensure delivered solutions meet business requirements, operational needs, and intended business outcomes.
• Support deployment, business readiness, training, change management, and continuous improvement activities to drive successful adoption and ongoing optimization of business processes and systems, including assisting Product Owners with business workflow documentation and work-instruction updates following system releases and rollouts.
• Support digital thread enablement (digitalization of experimental and operational workflows) and FAIR data practices.
• Retrieving/processing and visualization of data

• Master’s degree and 2+ years relevant work experience OR
• Bachelor’s degree and 3+ years relevant work experience
• Degree in Mechanical/ Chemical/ Biomedical Engineering or related field
• Prior understanding of Good Manufacturing Practices (GMP) requirements and their implication on software deployment
• Prior experience in the medical device/pharmaceutical/medical manufacturing industry
• Experience in Agile/Scrum
• Demonstrated prior work experience as a business systems analyst in the implementation of PLM and successful training and onboarding of users onto a PLM platform in a large multi-national company.
• Experience in a product development/commercialization function
• Strong communication and cross-functional collaboration skills - ability to distill, craft and present key messages relative to diverse audience requirements.
• Demonstrated ability…