Job Description

Key Responsibilities:

• Opcenter Execution Medical Device and Diagnostics (formerly known as \xe2\x80\x9cCamstar Medical Device Suite\xe2\x80\x9d) rollout with some customization.
• Work with end users, functional architects, and validation to deliver enhancements stories for MES and integration with ERP, PLM, eQMS, LIMs, LMS etc.
• Hep prioritize by participating in estimation process for stories.
• Configures and tests systems to execute features, integration, and reporting.
• Working knowledge of FDA regulated environment.
• Troubleshoot and improve MES implementation.
• Assist with the execution of projects, installations, upgrades, and revisions from design through deployment.
• MES Functional knowledge, Camstar Medical suite in-depth knowledge required. Including but not limited to Camstar Designer, Camstar Web Forms Builder, Camstar Open Adapter, SQL Server.
• Experience translating functional requirements into technical specifications
• Experience developing and supporting Manufacturing Execution Systems developed using Camstar
• Experience in designing Manufacturing Execution System solutions from requirements gathering through implementation and post-implementation support
• Excellent communication skills both verbal and written is required to be able to work remotely with multiple time zone team members.
• Serves as liaison between business process owners in Business Units, Functional Groups, Regions and IT. Enable super-users (by training and performing knowledge transfer) to leverage IT systems for business process automation and optimization
• Works with stakeholders in developing ROI based business cases for enhancements and small projects. Other duties as assigned by Leadership

• Bachelor\'s Degree in related field, 4 Years related experience Required or Master\'s Degree related field, 2 Years related experience Required.
• Hands on Camstar/Siemens Opcenter 2 yrs. minimum experience required.
• Experience in an FDA regulated industry, medical device or pharmaceutical preferred, but not required.

• Strong ability to manage and deal with different cultures and nationalities.
• Strong analytical and logical problem solving skills.
• Strong interpersonal relations, written & verbal communication skills.
• Organizational and project management skills a plus.
• Possess and display sound judgment; initiative; flexibility and detail-orientation.
• Ability to develop and maintain business and technical documentation.
• Provide mentorship to lower level Business System Analysts.
• Strong documentation skills.
• Competent in handling multiple tasks with attention to detail, and perform duties with minimal supervision.
• Ability to adapt to new technologies.
• Ability to adapt to rapidly changing environment.
• Ability to map, troubleshoot, and optimize interfaces with multiple systems.
• Experience working in complex, matrixed and global business environment.
• Experience managing small to medium IT projects.
• Experience with FDA guidelines for Software Quality and Systems Validation required.
• Experience with Good Manufacturing/Good Documentation Practices (GxP) processes required.
• Proven expertise in usage of MS Office Suite.
• Strong documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Prior experience working in complex global business environment.
• Prefer experience with FDA guidelines for Software Quality and Systems Validation is a plus.
• Substantial understanding and knowledge of enterprise information systems such as ERP, PLM, CRM, QMS, etc (such as JDE, SAP), PLM (TeamCenter, Agile), MES (such as CAMSTAR, APRISO, etc), CRM (such as Salesforce.com) APS (such as JDA, Manugistics, i2, SAP), QMS (such as Pilgrim, TrackWise, Master Control), LIMS (such as Labware), Calibration and Maintenance (such as Blue Mountain or Maximo) preferred.
• Experience with identifying, integrating, and managing SaaS solutions and external vendors.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Edwards Lifesciences