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Project Manager with Systems/Application background - Medical device

Company: Comrise
Location: Aliso Viejo
Posted on: May 1, 2021

Job Description:

Technical Leader enabling company growth by the identification and implementation of integrated software solutions company wide with a focus on Manufacturing and Supply Chain systems. Manager technical engineering resources and partner with business leaders to implement in-house solutions to integration of off the shelf solutions to meet customer needs. Typical duties include:

  • Develop and maintain product and process configurations and collaborate on the implementation of solutions in PLM, MES and ERP. Candidate must have a solid understanding of PLM/ERP and changes to downstream cross functional areas and systems
  • Identify, execute, and support process improvement initiatives of varying complexity engaging global, cross-functional support
  • Engage Subject Matter Experts (SMEs) to assure change and configuration documentation is accurate and complete, all relevant documentation is included, and appropriate implementation strategies and validation activities have been completed
  • Work with peers and/or subordinates to ensure timely completion of projects and tasks
  • Take initiative to develop and implement new processes to strengthen data accuracy or enhance efficiency
  • Demonstrate effective communication style working with all levels of organizational structure, through multiple departments, and across global sites
  • Provide leadership to junior level engineers
  • Proven ability to convert process flows into automated workflow models
  • Identify financial and/or quality opportunities from operations related areas such as manufacturing, receiving inspection, supply chain processes, warehouse
  • Work across departments to integrate systems to ease of use for those accessing the information
  • Identify areas where metadata can be leveraged to minimize or reduce redundant activities, inspections or data collection
  • Support operations on all attribute data collection practices to establish a best practice
  • Work with internal/external customers and all relevant parties to deliver services
  • Apply comprehensive understanding of concepts within own technical areas to design relatively advanced solutions; demonstrates understanding of key business drivers
  • Question current methods while evaluating broad implications, to develop practical improvements; focuses on achieving goals
  • Understanding of master data and the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing
  • Review and monitor implementation activities to ensure the change has been completed properly Qualifications
  • Bachelors degree in SW Engineering, Electrical Engineering or related discipline
  • Must have at least six (6) years experience in software development and/or software engineering
  • A minimum of one (1) year leadership or supervisory experience
  • Demonstrated project management
  • Experience in configuration management, operations, and/or quality within a regulated industry
  • Software/Hardware and embedded systems experience
  • Solid communication skills
  • Programming and ERP systems experience
  • Technical background in manufacturing, preferably in a life sciences, diagnostic, and/or medical device environment
  • Solid understanding of computer system and manufacturing validations
  • High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment
  • Able to work independently and requires minimal guidance to perform required tasks Requirements
  • Experience with Software Development Life Cycle of controlled systems preferred
  • Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP preferred
  • Product Lifecycle Management (PLM) experience
  • Experience with ISA-95 with a strong understanding for the boundaries between enterprise and control systems
  • Working knowledge of ISO 13485 and cGMP requirements desired - provided by Dice

Keywords: Comrise, Aliso Viejo , Project Manager with Systems/Application background - Medical device, Healthcare , Aliso Viejo, California

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