Senior Process Engineer

US-CA-Rancho Santa Margarita

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Applied-Medical-Logo-w-Tag_H_Teal_cropped

 

Senior Process Engineer

 

Applied Medical is a rapidly growing, global organization that develops, manufactures and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all of our processes in-house, from R&D concept to clinical implementation. Applied Medical engineers take a hands-on approach, utilizing in-house cutting-edge technologies, such as automation and robotics, advanced metal processing, injection molding, and rapid prototyping. We invest heavily in R&D, advanced technologies and most importantly – the growth of our team members.                                                                                

Applied Medical is proud to have a culture firmly grounded in teamwork, collaboration and regulatory compliance, while providing opportunities for growth and choice in individual career paths.

Position Description

As a Senior Process Engineer, you will use skills related to sustaining and improving production manufacturing processes as part of a cross-functional team.

 

Provide guidance on and complete the following:

  • Lead projects to develop and sustain manufacturing processes
  • Debug manufacturing processes and equipment via root cause analysis
  • Run, observe and expedite shop orders
  • Develop and review engineering documents such as process maps, process FMEA, Manufacturing/Quality Instructions, test methods, drawings, and test reports
  • Investigate materials, manufacturing processes and technologies
  • Research and qualify new suppliers and vendors
  • Review and evaluate non-conforming materials, address customer experience reports, perform root cause analysis, and propose corrective/preventative actions
  • Provide technical guidance to other team members and train as necessary on manufacturing documentation, prototype generation and data analysis
  • Identify project critical paths in order to define project priorities and manage resources
  • Develop contingency plans for alternative project paths as necessary
  • Collaborate with the Production team to identify capabilities and capacity
  • Collaborate with the Engineering team for fixturing and tooling design, tolerancing, and design for manufacturing

Position Requirements

This position requires the following skills and attributes:

  • 5+ years of relevant Engineering work experience
  • Bachelor’s degree in Mechanical, Biomedical, Industrial, or Manufacturing Engineering (or equivalent) 
  • Extensive experience with manufacturing equipment and processes
  • Extensive experience with computer-aided design (i.e. SolidWorks), spreadsheets, scheduling programs, and word processing
  • Experience with technical writing
  • Experience with Statistical Process Control (SPC)
  • Working knowledge of Geometric Dimensioning and Tolerancing (GD&T)
  • Knowledgeable about a variety of materials and mechanical designs
  • Ability to effectively manage projects and work in cross-functional teams
  • Excellent written and verbal communication skills and ability to effectively present information
  • Technical aptitude and detail oriented 

Preferred

  • Experience in the medical device industry
  • Understanding of manufacturing and quality standards, including FDA regulations and ISO quality systems
  • Experience with software such as NetWeaver/Product Lifecycle Management
  • Experience with Minitab or other statistical analysis software

Benefits

  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental coverage
  • Education reimbursement program
  • 401(k) program with employer match
  • Generous holiday and vacation accrual

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