Sr. Engineer, Manufacturing/Processing

Axogen•Vandalia, OH

1d•$84,190 - $105,237•Onsite

About The Position

The Sr. Manufacturing Process Engineer will provide focused project leadership and technical support to Operations with an emphasis on project management, equipment qualification, standard operating procedures, standard costing, capacity analysis, yield improvements, cost reduction, planning, validations and metrology.

Requirements

Bachelors degree in Engineering or related science with 5 years of experience
Medical device, biologic or HCTP experience
A minimum of 5 years experience in Manufacturing Engineering, Process Design Engineering, Process Optimization, or Process Development preferably with a regulated medical product.
Proven project leadership / management skills
Oral & written communications skills
Computer software skills including but not limited to: MS Office, database, Excel, and MS Project
Willingness to process and handle human and animal tissue based products
Job includes, but is not limited to: verbal communication, typing, standing, sitting, walking, pushing, pulling, stooping, and seeing
Position will require travel up to 20%

Nice To Haves

Lean manufacturing and/or process controls experience a plus

Responsibilities

Supports production to maintain inventory flow and levels to meet demand
Addresses issues (e.g. NCR, CAPA) quickly and effectively
Plans, leads, and executes complex cross functional projects impacting operations and other areas of the business
Leads continuous improvements activities of productivity, quality, cost, cycle time and yield of raw material
Leads efforts to maintain and improve quality of existing operations, processes, and products
Represents operations on new product development Develops and implements associated processes.
Analyzes product or equipment specifications and performance requirements to determine feasibility of new plant equipment or modifying existing equipment
May include reporting duties for multiple interns and/or engineers
Analysis and recommendations for capital equipment investments
Being a focal point for technical communications on quality issues
Utilizing root cause analysis methods and statistical tools to resolve processing
Using statistical methods to determine in-control/out-of-control
Developing and implementing methods and procedures for inspecting, testing and evaluation of products for acceptability
Leads the development and execution of equipment installation and operational
Leads in the development and execution of process
Leads in developing and maintaining support systems for production work processes
Supporting integration of new business work processes
Maintenance of the calibration program