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
- Will work in our Birth Tissue business primarily
- Versatility can work Musculoskeletal or Birth Tissue
- Tissue experience preferred
- Lab environment / clean room is needed
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.
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