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Associate VP, Engineering and Automation (Cincinnati)

Associate VP, Engineering and Automation (Cincinnati)

Enable Injections IncCincinnati, OH, US
12 hours ago
Job type
  • Part-time
Job description

Associate VP, Engineering and Automation

Qualifications

Required :

  • Technical bachelor's degree
  • 15+ years of experience in development and manufacturing of medical device processes and equipment
  • 7+ years of experience leading manager level personnel, teams and projects
  • Experience in developing and commercializing regulated devices / combination products under FDA (21 CFR 820), ISO 13481 and ISO 14791 requirements
  • Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
  • Strong hands-on technical leadership skills with a proven track record of equipment and automation design and implementation
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
  • Demonstrated ability to prioritize tasks and lead a varied workload
  • Demonstrated extraordinary problem-solving ability
  • Strong leadership, influencing and negotiating skills

Preferred :

  • Advanced degree (technical or business) or trades background
  • Management experience of engineering teams
  • Prior experience in discrete medical device manufacturing
  • Prior experience leading projects with external design, development and manufacturing partners
  • Knowledge of available design tools such as SolidWorks software

    • Skills & Competencies :

  • Demonstrated ability to prioritize tasks and lead a varied workload
  • Able to lead technical individuals and assist with complex problem solving using engineering principles
  • Excellent verbal and written communication
  • Developing effective technical and business presentations
  • Managing resources in a dynamic environment
  • Demonstrate strong leadership, management, and team work qualities
  • Expertise in equipment design and build, working knowledge of IQ / OQ / PQ validations, product line design and build
  • Ability to perform capacity planning and budgeting

    • Physical Requirements :

  • Must be able to work at a desk or remain stationary for extended periods of time
  • Must be able to access and navigate all areas of the facility, including clean rooms
  • Ability to operate a computer and other office equipment, such as printer, telephone, etc.
  • Ability to travel up to 30% domestically and internationally

    • Responsibilities

  • Provide project(s) and technical leadership to engineering development team for creation of processes and equipment as well as assembly line design to comply with medical device regulations
  • Establish and drive detailed equipment plans, define risks and recommend contingency plans
  • Establish and foster strong collaborative relationships with external design / development, manufacturing partners and service providers
  • Lead internal advanced development function aim at fast turn prototyping, fixture development and machining capabilities
  • Participate in the operational planning activities ensuring alignment to manufacturing strategy
  • Promote visibility and transparency of information within engineering development to accelerate decision making, obtain alignment, and increase foundational knowledge and output
  • Identify appropriate manufacturing strategies that match Enable product and pharma partner goals
  • Understand and follow the Enable procedures with a focus on quality
  • Manage overall project risk through comprehensive mitigation assessment and planning techniques and be responsible for working with partners to develop plans and project risk analyses
  • Communication includes : departmental, cross functional and project / program information as well as any status updates as needed
  • Define key project and manufacturing constraints such as scope, schedule, budget, resources and risks
  • Clearly communicate roles, expectations and accountabilities to team members on a regular basis
  • Serve as the lead contact for all internal partners regarding engineering development activities and establish and maintain relationships with all partners as needed
  • Be responsible for creation and approval of engineering budget (as appropriate)
  • Liaise with functional managers or partners as needed to ensure development goals are achieved and lead teams and work with management to resolve resource gaps

    • Nearest Major Market : Cincinnati

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    Vp Engineering • Cincinnati, OH, US

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