Sr. Manufacturing Process Development Engineer

Salary depends on experience
Posted on 06/29/18
Aliso Viejo, CA
5 - 7 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 06/29/18

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.
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