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 ID 4772BR
- Aliso Viejo, California, USA
Apply for this job
- Must have a Bachelor’s degree in Engineering or a related field
- Must be bilingual English/Japanese
- Must have five (5) or more years of related experience
- Experience with Continuous Process Improvement and Process Validations within a medical device manufacturing environment
- Proficiency in Solidworks and fixture/tooling design
- Six Sigma Green Belt
- Strong creative and critical thinking skills
- 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
- Ability to work in a fast-paced, cross-functional environment
- Supervisory experience and/or experience leading a team or project
- Successful completion of a process validation
- Lean Manufacturing experience
- Catheter design/manufacturing experience
- Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development characterization and optimization
- Six Sigma Black Belt
- 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.