Engineering Manager - Medical Devices
Job Opportunity at Surf Search

Posted on May 31

http://www.surfsearch.org    858-876.8801

Location: Irvine, CA
Job Type: Full Time
Job ID: W4160807

Engineering Manager - Medical Devices

Industry leading medical devices company seeks an Engineering Manager to lead a process development and tech transfer team in the development of a new Class III electromechanical implantable medical device.

The person in this position will be responsible for partnering with a CRO/CMO to develop and execute the transfer strategy and select a larger CMO once the product is commercial. Initially anticipated travel will be 75% both domestic and international.   

The Engineering Manager will:
  • Develop and execute project operations integration plan 
  • Manage pilot production builds
  • Plan and manage manufacturing budget, including capital and operating expenses
  • Develop, execute and own process validation plan
  • Manage manufacturing risk assessment and mitigations, through hands on work and developing action plans

Requirements for Engineering Manager:
  • Bachelor's degree in engineering, preferred disciplines would include mechanical engineering, manufacturing engineering or industrial engineering.  Advanced degree preferred
  • 8+ years of progressive experience leading medical device tech transfer projects, scale up from pilot to full manufacturing production
  • Experience supporting the manufacture of electro-mechanical medical devices
  • A track record of accomplishment in developing production process requirements, specifications.
  • Experience working with design firms and contract manufacturing and operations to develop best production systems
  • Experience identifying and developing contract manufacturing partners strongly preferred
  • Strong project management experience
  • Demonstrated excellence in moving medical devices through design transfer to operations (full manufacturing)
  • A technical background strong in manufacturing engineering, including DFM (Design for Manufacturability, process excellence methodologies, Six Sigma, Lean, supplier development and process validation.  Experience in design control and various country regulations, including FDA and EU
  • Strong analytical, organizational and leadership skills and a track record of accomplishment working with influencers and cross functional teams
  • The ability to travel up to 75% both domestically and internationally

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