Manufacturing Engineer

Title: Manufacturing Engineer

Location: Phoenix AZ

Start: ASAP

Schedule: M-F

Duration: Direct Hire

Education:

Bachelor's Degree in Engineering/Science (Biomedical, Chemical, or Mechanical Engineering preferred)

Requirements:
- Minimum of 3 - 5 years of process or manufacturing engineering experience within a pharmaceutical, medical device, biologic, tissue bank, diagnostic, hospital, or similar organization
- Minimum of 3 - 5 years of experience participating in process development, equipment qualifications, process validation protocols and reports, and executing validation protocols
- Daily verbal and written communication with Operations leaders, R&D staff, and Finance

Preferred:
- Experience in applying statistical methods and lean manufacturing principles for product, process, and quality improvements.
Project Management experience .
- Experience in design control and process validation, process capability, control, and monitoring analysis, root cause analysis, corrective and preventive action (CAPA), sterilization validation, and packaging validation.

Responsibilities:

- Lead 3-5 R&D NPD, new equipment, and/or process improvement projects including periodic management status reports and associated KPIs.

- Create and maintain equipment capacity studies escalating and addressing conflicts to the 12-month S&OP Demand projections.
- Create and maintain a campus layout plan contemplating future growth, new equipment, planned staffing levels, product and materials flow, and S&OP defined future production volumes and product mix.
- Master and deploy Lean principles across all operations
- Working knowledge of 6-sigma, GR&R, SPC, 8D, and other quality system concepts and tools.
- Lead Processing Technician staff training materials relative to content, format, and presentation migrating from "Read and Understand" to photographic and video-based materials.