In this role you will use sound and proven engineering principles to assist in developing and implementing processes and requirements. Working as a member of a technology team, you will collaborate with other engineers, management, and operators.
This position will support current manufacturing and scale up new products from R&D. Involvement may begin from feasibility at vendors to full scale manufacturing.
- Analyzes existing manufacturing processes and in-process tests. Streamlines production lines to reduce overall production costs.
- Investigates field failures. Performs failure analysis and determines root cause. Designs and validates product enhancements to improve product reliability.
- Demonstrate hands-on process understanding and provide guidance and training with plant operators on engineering level builds.
- Design and develop fixtures and equipment components required to meet process goals from concept to implementation.
- 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.
- 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.
- Independently manages and prioritizes projects, tracks progress toward overall goals, and provides periodic updates to management.
- Assembles and analyzes pareto charts for yield failure modes and creates and drives action plans to address yield loss.
- Perform statistically robust and industry standard analysis of data, and present findings to technical teams
- Develops, validates and implements improvements to increase throughput and improve manufacturing yields.
- Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system.
- Create and execute equipment qualification documents (IQ/OQ/PQ) and process validations.
- Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
- Proven ability to work hands-on in a fast-paced environment.
- Typically requires a B.S. in Mechanical Engineering, Bioengineering, Materials Science or equivalent with 0-2 years related experience or an
- M.S. in Mechanical Engineering, Bioengineering or equivalent with 0-1 year related experience. (Medical Device/Biotech experience desired)
- Ability to run self-directed projects, maintain timelines, stay organized, and balance multiple activities in a fast-paced environment
- Familiar with experimental design, data analysis, and interpretation of experiments.
- Excellent communication (written and verbal) and personal interaction skills
Qualification & Experience:
- Proficient in the use of SolidWorks or equivalent CAD software.
- Lean Six Sigma or Six Sigma DMAIC methodology
- Experience in DFA/DFM
- Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 0-2 years related experience.
- Manufacturing or sustaining experience
- Experience with semi-automated and automated manufacturing equipment
- Medical device experience
- JMP or Minitab experience
Vacancy Type: Full Time
Job Location: San Diego, CA, US
Application Deadline: N/A