Job Description

Education Required: Bachelors Degree

Years’ Experience Required: 10

Top 3 things the manager is looking for in a candidates experience:

1. Winchill PLM SME and strong industry / business knowledge and PLM solution implementation experience required.  
2. Experience configuring PLM applications and integrations (Windchill experience preferred)
3. Multiple complete Product Lifecycle Management (PLM) implementations

Top 3 Tasks or Responsibilities in scope for this role:

1. Advises Business Operating Unit / Functions & Business Workstream Leads on how to best design PLM processes / solutions. Leads all BA activities related to functional requirements, solution design, process creation, technical documentation, and IT compliance for ALL Program Waves in their PLM Capability/Process area.
2. Evaluate current business processes and identify complex business problems and translate those needs into how those needs can be satisfied within the company's PTC Windchill PLM solution.
3. Provides technical expertise for system functional specifications and deploys new and current systems, processes, and procedures in a cost-effective manner leveraging PTC Windchill as PLM solution.

Description: 

As a Senior Principal IT Business Analyst on the Product DNA Execution team, you will be a key member of a multi-year Product Lifecycle Management enterprise IT program implementation team (moving off of Oracle Agile/Enovia into Windchill) with a focus either on Regulatory, Design & Engineering, Supplier, or Operations Process related PLM business capabilities. This role will lead a value stream within IT interacting and driving business requirements, SAP, Master Data Management, etc integrations into Windchill, and providing technical SME.  

• Advises Business Operating Unit / Functions & Business Workstream Leads on how to best design PLM processes / solutions. Leads all BA activities related to functional requirements, solution design, process creation, technical documentation, and IT compliance for ALL Program Waves in their PLM Capability/Process area.
• Plays key role in validation activities and usability pilots. 
• Strong industry / business knowledge and PLM solution implementation experience required.  
• Engages with business leaders to understand how strategies and product data-driven changes can improve efficiencies and add value
• Evaluate current business processes and identify complex business problems and translate those needs into how those needs can be satisfied within the company's PTC Windchill PLM solution.
• Partners with various IT teams to design technology solutions that align with Enterprise Architecture strategy and standards, are compliant with GSO and Data Privacy, or other applicable regulations, and IT processes.
• Provides technical expertise for system functional specifications and deploys new and current systems, processes, and procedures in a cost-effective manner leveraging PTC Windchill as PLM solution.
• Advises business team members on business process options.
• Oversees cross-functional teams to address business/systems issues or project.
• Interacts with internal and external customers and vendors at various levels
• Manages stakeholders’ expectations and provides briefings to senior leaders
• Facilitates discussions to negotiate and reach understanding or agreements to solve business and technical challenges in the most optimal way
• Facilitates interviews to gather requirements, document current process, and design future state
• Collaborate with IT Business Relationship Manager (BRM), business stakeholders and IT Product Owners / Managers to develop business requirements for product or system changes
• Translates and documents business requirement(s) into Functional Specifications 
• Drives business agenda during solution delivery process
• Responsible for technical solution delivery
• Establish backlog of user stories and specify the “WHO, WHAT, WHY” as well as Acceptance Criteria
• Ensure applicable compliance and regulatory requirements are recorded.
• Oversee testing and defect management process for User Acceptance Testing (UAT).  
• Coordinate demos, conference room pilots and testing.
• Support training content creation.
• Help build the institutional solution knowledge for long-term business understanding & support.
• Work w/ Global Process Lead to update QMS document per process changes.
• Work w/Validation Lead to author/update applicable validation documents in conformance with System Compliance Methodology (MSCM).

TECHNICAL SKILLS
Must Have

• Ability to create technical specifications to document business requirements
• Ability to troubleshoot technical and configuration issues within PLM applications
• Agile Product Lifecycle Management
• Application Integrations
• Corrective & Preventive Action (CAPA), Issue Impact Assessment (IIA) and Non-Conformance Integration
• Experience Configuring PLM Applications (Windchill Preferred)
• Experience with master data management.
• Experience with other Product data platforms such as PLM (Enovia, Agile PLM, Windchill), ERP, PIM, etc
• Knowledge of Quality Management Systems (QMS)
• Maintaining configuration control and Risk management through systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk.
• Multiple complete Product Lifecycle Management (PLM) implementations
• Product Development Process, Enterprise Change Control, Design Control, Supplier Control, and related Regulatory aspects
• Solid experience with activities throughout the product lifecycle, related to requirements and specs to ensure that a product, service, or system meets, and fulfills its intended purpose including:
• Strong interpersonal, oral, presentation, and written communication skills
• The management of requirements by identifying, analyzing, decomposing, allocating and resulting traceability to system components
• VOX informed design for systematically gathering and interpreting feedback from customers, regulatory sources, competitors, and other stakeholders on the use of a product to guide the development of new, related products or improvements on an existing product.
• Windchill

STRONGLY Preferred Qualifications:

• Multiple complete Product Lifecycle Management (PLM) implementations
• Experience configuring PLM applications (Windchill experience preferred)
• Proven experience in leading the shaping of business requirements, designing solutions to meet the requirements, educating business stakeholders on system capabilities and options to improve business processes
• Ability to create technical specifications to document business requirements
• Ability to troubleshoot technical and configuration issues within PLM applications
• Strongly Preferred Data/Process/Systems Knowledge & Experience:
• Solid experience with activities throughout the product lifecycle, related to requirements and specs to ensure that a product, service, or system meets, and fulfills its intended purpose including: 
• The management of requirements by identifying, analyzing, decomposing, allocating and resulting traceability to system components
• Maintaining configuration control and Risk management through systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk. 
• VOX informed design for systematically gathering and interpreting feedback from customers, regulatory sources, competitors, and other stakeholders on the use of a product to guide the development of new, related products or improvements on an existing product.
• Product Development Process, Enterprise Change Control, Design Control, Supplier Control, and related Regulatory aspects
• Corrective & Preventive Action (CAPA), Issue Impact Assessment (IIA) and Non-Conformance Integration
• Document approval and Document change management for Quality Management System (QMS) 
• Experience with master data management.
• 7+ years of professional experience in the healthcare industry strongly preferred
• MedTech experience
• Experience with patient data and clinical reporting
• Knowledge of pre/post market surveillance and real-world evidence
• Strong knowledge and understanding of EU MDR requirements.
• Strong technical aptitude and knowledge on latest technology trends.   
• Strong interpersonal, oral, presentation, and written communication skills. 
• Ability to work collaboratively. Excellent facilitation and issue resolution skills.
• Proven record of impactful contribution to enterprise-wide projects.
• Able to adapt to ambiguity, adept at change management, and capable of working in cross functional teams.
• Drive for continuous improvement and a passion to be a change agent.
• Experience driving work across a global, matrixed organization.
• Experience working in an FDA/ISO regulated environment.
• Experience with other Product data platforms such as PLM (Enovia, Agile PLM, Windchill), ERP, PIM, etc.
• Knowledge of Quality Management Systems (QMS) 

Job Tags

Remote job, Contract work,

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