Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system.
- This position assumes and performs other duties as assigned.
- Develop and maintain project timelines and provide updates and feedback to project leadership.
- Demonstrate hands-on process understanding and provide guidance and training to operators and techs on engineering builds
- Perform statistically robust and industry standard analysis of data, and present findings to technical teams
- Demonstrate hands-on process understanding and provide guidance and training with pilot plant operators on engineering level builds.
- Plan and perform Design of Experiments (DOE) to characterize and determine optimal processing methods
- Assist in the development of project timelines and provide technical updates and feedback to project leadership
- Assist in scaling up equipment and processes from prototype to pilot to full scale manufacturing. Provide design and assembly requirements working within scope as determined by business and schedule needs.
- Confer with vendors to produce equipment, materials, and/or parts that meet determined product specifications
- Implement, characterize, and optimize processes, mechanical tests, and fixtures/jigs for assembly, inspection and test through implementation of measurement systems, part inspections, MSA, and capability analysis.
- Create and release equipment specifications and drawings, establish calibration and preventative maintenance requirements.
- Exercise judgment within defined procedures and policies to determine appropriate action.
- Identify process risks and track mitigations through standard methods.
- Design and develop fixtures and equipment components required to meet process goals from concept to implementation.
- Proficient in the use of SolidWorks or equivalent CAD software.
- Manufacturing or sustaining experience
- Medical device experience
- Excellent communication (written and verbal) and personal interaction skills
- Lean Six Sigma or Six Sigma DMAIC methodology
- Proven ability to work hands-on in a fast-paced environment.
- Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
- Familiar with experimental design, data analysis, and interpretation of experiments; JMP experience or Minitab preferred
- Knowledge of high reliability, high volume manufacturing processes and designs.
Vacancy Type: Full Time
Job Location: Mesa, AZ, US
Application Deadline: N/A