Staff Process Engineer

Summary:
In this role as a Staff Process Engineer – MY Deployment, you will use sound and proven engineering principles in the implementation, characterization, improvement, and qualification/validation of manufacturing processes for replicate manufacturing equipment used in the scale-up of new or existing products.

Essential Duties and Responsibilities:

1. Responsible for improvement, optimization, and implementation of manufacturing process/assembly steps and operating procedures for replicate equipment and processes within a regulated quality system.
2. Lead or support equipment/process qualifications including protocol development and execution.
3. Develop and maintain project timelines and provide updates and feedback to project leadership.
4. Effectively implement problem-solving skills and techniques to identify potential process risks, assess their impact, developing and implementing mitigation plans.
5. Plan and perform Design of Experiments (DOE) and utilize six sigma methodologies to characterize, assess capabilities, and determine optimal processing operating windows.
6. Consult with vendors to produce equipment, materials, and/or parts that meet determined product specifications.
7. Perform statistically robust and industry standard analysis of data, and present findings to technical teams.
8. Exercise judgment within defined procedures and policies to determine appropriate action.
9. Transferring process knowledge and understanding to receiving site operations teams along with providing technical training for responsible processes.
10. Assist in the development of project timelines and provide technical updates and feedback to project leadership.
11. Consult with AME Process Engineering in scaling up equipment and processes from prototype to pilot to full scale manufacturing.
12. This position assumes and performs other duties as assigned.

Required Qualifications:

1. Typically requires a B.S. in Mechanical Engineering, Bioengineering, Chemical Engineering, Materials Science or equivalent with 5+ years related experience, preferred or an M.S. in Mechanical Engineering, Bioengineering or equivalent with 3+ years related experience.
2. Ability to run self-directed projects, maintain timelines, stay organized, and balance multiple activities in a fast-paced environment.
3. Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
4. Proven ability to work hands-on in a fast-paced environment.
5. Familiar with experimental design, data analysis, and interpretation of experiments; JMP experience, Statgraphics or Minitab preferred.
6. Excellent communication (written and verbal) and personal interaction skills.
7. Knowledge of high reliability, high volume manufacturing processes and designs.