Sr. Manufacturing Process Development Engineer

MicroVention Terumo   •  

Aliso Viejo, CA

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 164 days ago

This job is no longer available.

Position Overview

The Sr. Manufacturing Process Engineer provides manufacturingsupport for existingprocesses and for new products, product changes, line extensions and enhancements, as well as related tooling and fixtures. Typicalresponsibilitiesinclude:

  • Support validation of product, equipment and processes.
  • Interface with other departments to solve manufacturing production problems.
  • Monitor equipment maintenance program.
  • Investigation and testing of product processes.
  • Support prototype and pilot production, facilities and planning, when appropriate.
  • Lead manufacturing efforts associated with new product transfer between R&D and manufacturing.
  • Evaluates, creates and initiates improvements to existing engineering and project systems
  • Provides support with execution of capital equipment build projects, including technical documentation (drawings, BOMs, specs, reports), builds procurement and customer interaction
  • Works closely with prototype lab and Machine Shop to provide clear documentation and communication, to allow for efficient fabrication
  • Develops documentation expertise related to equipment mechanical design and manufacturing processes
  • Searches and implements new technologies to improve manufacturing processes and equipment design
  • Performs other duties and responsibilities as assigned

Job Details

    • Job ID 4772BR
    • Aliso Viejo, California, USA

Apply for this job

  1. Must have a Bachelor’s degree in Engineering or a related field
  2. Must be bilingual English/Japanese
  3. Must have five (5) or more years of related experience
  4. Experience with Continuous Process Improvement and Process Validations within a medical device manufacturing environment
  5. Proficiency in Solidworks and fixture/tooling design
  6. Six Sigma Green Belt
  7. Strong creative and critical thinking skills
  8. Excellent communication skills including the ability to present proposals to end-users of technology, equipment, tools/fixtures to achieve user acceptance, and negotiate with customers and vendors
  9. Ability to work in a fast-paced, cross-functional environment

Desired Qualifications

  1. Supervisory experience and/or experience leading a team or project
  2. Successful completion of a process validation
  3. Lean Manufacturing experience
  4. Catheter design/manufacturing experience
  5. Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development characterization and optimization
  6. Six Sigma Black Belt

Additional Information

  • The primary work locations for this position are Aliso Viejo, CA and Tustin, CA.
  • Candidates must be eligible to work in the U.S. and not require visa sponsorship.