Manufacturing Operations Manager

Research & Development · Columbus, Ohio
Department Research & Development
Employment Type Full-Time
Minimum Experience Experienced

General Description:


Apply your creativity and passion to develop innovative medical devices that can greatly improve
patients’ lives. We take pride in a truly entrepreneurial environment, unique technical challenges and a
collaborative culture. We welcome you to explore Avation and be part of a talented team and an
exciting company.


Key Responsibilities:


  • Plan, execute and lead manufacturing operations for new medical device systems
  • Manage and train manufacturing operators, technicians and inspectors
  • Set up production line, equipment and develop manufacturing processes
  • Define yield targets, create process FMEA and statistical process controls
  • Create manufacturing process documentation including device history records
  • Lead plans for finished goods, system packaging and labeling
  • Facilities Management in compliance with OSHA, cGMP and safety procedures
  • Lead, track and investigate non-conformances, CAPA and production issues
  • Monitor and maintain manufacturing equipment and fixture requirements
  • Plan production, KPI’s and inventory schedules based on forecasts
  • Plan and conduct process validation – IQ/OQ/PQ
  • Key part of project teams in transferring designs into scalable manufacturing


Qualifications:


  • Bachelor’s in Mechanical or Industrial Engineering
  • Minimum 8-12 years of professional experience, including 3 years in medical device manufacturing
  • In-depth knowledge of 21 CFR 820, ISO 13485, GMP and FDA requirements
  • Familiarity with principles of Six Sigma, lean manufacturing
  • Direct experience with packaging and labeling for medical devices
  • Familiarity with electromechanical products, software and medical device development
  • Ability to multi-task and collaborate on cross-functional projects
  • Strong team leadership with ability to enforce discipline and schedules
  • Independent, creative, collaborative with strong positive can-do attitude


Avation Culture


We are seeking candidates who are:

  • Driven by the desire to bring innovative medical technologies to market
  • Passionate about applying themselves to improve the lives of patients
  • Intellectually curious, motivated by innovation and open to new ideas
  • Leaders who take individual ownership while placing high value on teams
  • Energetic and enjoy working in a fast-paced creative environment


Location: Columbus, OH


 

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  • Location
    Columbus, Ohio
  • Department
    Research & Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced