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Sr. Engineer (R&D/Manufacturing)

Orange County Metro Area, CA

Posted: 02/15/2019 Job Type: Engineering Job Number: JN -022019-23706
Sr. Engineer (R&D/Manufacturing)
Life Sciences Industry
Irvine, CA

  • Create, characterize, and implement new manufacturing processes including leading the design, procurement and qualification of manufacturing equipment and tooling for NPD/ VE projects
  • Develop solutions to manage complex manufacturing process design, development and validation efforts from early product development through product launch
  • Transfer processes from R&D to Manufacturing using project management, design for manufacturability and cost, process/design excellence, LEAN, ergonomics and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology
  • Development of process specifications which ensure user needs are met
  • Perform equipment and process qualifications (TFIQ/IQ/OQ/PQ) as needed
  • Drive incorporation of technical advancements into manufacturing process and technology employed in the manufacture of both existing and new products
  • Work and effectively communicate in a high energy, cross functional team and multiple site environments which includes product design, regulatory, quality, procurement, supply chain, supplier quality and operations to ensure project objectives are met
  • Continuously improve existing processes, manufacturability and sustainability
  • Accountability (including hands on and resourceful) on troubleshooting, problem solving, and escalation of program risk to management when design transfer and scale-up to manufacturing do not work as expected
  • Knowledge of Solidworks
  • Experience with automation, semi-automation and/or ultrasonic welding/swaging preferred
  • Demonstrated use of process and design excellence methodologies including Six Sigma
  • Knowledge of Design for Manufacturability, and LEAN methodology
  • Ability to develop process requirement/ specifications, collaborate with outside design firms and work with Operations personnel
  • Effective knowledge of design transfer
  • Knowledge of cGMP, EHS guidelines, FDA guidelines and Process Validation
  • Capable of analyzing and solving complex problems through innovative thought and experience
  • Strong verbal/written communication and interpersonal skills including conflict and relationship management

  • A Bachelor's degree in engineering discipline is required; preferably Mechanical, Biomedical, or Manufacturing Engineering
  • A minimum of 4 years of experience in medical device manufacturing is required
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