Avation Medical

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

 

Search Firm Representatives Please Read Carefully

Avation Medical does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.