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Systems engineering manager

Medical device

Systems engineering manager

Aliso Viejo, CA
Full Time
Paid
  • Responsibilities

    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

    1. Bachelors degree in SW Engineering, Electrical Engineering or related discipline
    2. Must have at least six (6) years experience in software development and/or software engineering
    3. A minimum of one (1) year leadership or supervisory experience
    4. Demonstrated project management
    5. Experience in configuration management, operations, and/or quality within a regulated industry
    6. Software/Hardware and embedded systems experience
    7. Solid communication skills
    8. Programming and ERP systems experience
    9. Technical background in manufacturing, preferably in a life sciences, diagnostic, and/or medical device environment
    10. Solid understanding of computer system and manufacturing validations
    11. 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
    12. Able to work independently and requires minimal guidance to perform required tasks

    Requirements

    1. Experience with Software Development Life Cycle of controlled systems preferred
    2. Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP preferred
    3. Product Lifecycle Management (PLM) experience
    4. Experience with ISA-95 with a strong understanding for the boundaries between enterprise and control systems
    5. Working knowledge of ISO 13485 and cGMP requirements desired

     

    Company Description

    Medical Device Manufacturing Company